We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of Dynamic Elastomeric Fabric Orthosis (DEFO) on Sitting Balance and Gross Manuel Dexterity in Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03191552
Recruitment Status : Completed
First Posted : June 19, 2017
Results First Posted : December 14, 2017
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To evaluate the effects and feasibility of lycra based compression garment called Stabilizing Pressure Input Orthosis (SPIO) vest on posture and balance during sitting and gross manuel dexterity, parent satisfaction with the garment and to to compare 2 hours vs 6 hours of daily wear time.

Condition or disease Intervention/treatment
Cerebral Palsy Postural; Defect Device: SPIO Other: conventional exercises

Detailed Description:

Cerebral palsy (CP) is a disorder of development of movement and posture due to non-progressive lesion in fetal or infant brain. Postural control in children with cerebral palsy (CP) is deteriorated due to inappropriate muscle force and lack of sensory integration. The trunk which is found in the centre of the body plays a crucial role in postural control. Research and treatments in CP have focused on extremities rather than trunk control. Both evaluation and treatment of trunk impairment have not been adequately addressed in previously published studies. Improved proximal stability obtained by a better trunk control may lead to improvements in upper extremity function.

Dynamic elastomeric fabric orthosis (DEFO) which are lycra based compression garments provide extra proprioceptive information which enhances body awareness. The more correct proprioceptive input result in the more proper alignment. Vest type dynamic elastomeric fabric orthosis (DEFO) is composed of a front part which is compromised of double-or triple-layer of lycra fabric attached to velcro sensitive neoprene back panel. Thus, it provides adjustable compression around the shoulder, trunk, pelvis, and hips. It is proposed that these orthotic garments provides stabilization of the trunk, shoulder and pelvis girdle and thus improve proximal stability and upper extremity function. Children with sensory deficits and poor muscle strength including children with neuromotor developmental disorders and hypotonia can benefit from the use of vest type dynamic elastomeric fabric orthosis. Severe restricted pulmonary function and refractory cyanosis are absolute contraindications for lycra based orthosis use while having severe reflux symptoms, uncontrolled epilepsy, cardiovascular circulatory disorders and being diagnosed with diabetes are relative contraindications. The adverse events pertaining to the use of these orthoses are difficulty in donning/doffing, toileting problems such as constipation and urinary leakage, decrease in respiratory function, heat and skin discomfort. Due to those unwanted effects, it can be assumed that longer wear time of the orthosis may lower compliance. However, the optimal wear time for vest type dynamic elastomeric fabric orthosis has not been established so far. The reported wear time of suit therapies range from 2 to12 hours a day during 2-12 weeks. The aim of this study was to investigate if the use of a vest type dynamic elastomeric fabric orthosis (DEFO) vest type dynamic elastomeric fabric orthosis is feasible or not and will lead to improvement in sitting balance, sitting as a gross motor function and gross manuel dexterity. The secondary purposes of the present study are to evaluate parent satisfaction with the orthosis and to compare 2 hours vs 6 hours of daily wear time.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Observational Model: Cohort Time Perspective: Prospective Randomized controlled trial
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Vest Type Dynamic Elastomeric Fabric Orthosis (DEFO) on Sitting Balance and Gross Manuel Dexterity in Children With Bilateral Cerebral Palsy: A Feasibility and Randomized, Single-blinded, Pilot Study
Actual Study Start Date : June 20, 2017
Primary Completion Date : August 20, 2017
Study Completion Date : September 20, 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: SPIO 2 hours

All children will be hospitalized for 2 weeks and will receive conventional exercise therapy including range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills during hospital inpatient stay throughout 2 weeks 2 hours a day.

SPIO 2 hours group will receive conventional exercise therapy with the garment on for 2 hours.

Device: SPIO

SPIO (stabilizing input pressure orthosis) 2 hours will receive conventional exercise therapy with the garment on during 2 hours. SPIO 6 hours group wore the SPIO 4 hours more in addition to 2 hours during therapy.

SPIO 6 hours group will wear the SPIO 4 hours more in addition to 2 hours during therapy.

(conventional exercises :range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills

Other: conventional exercises
range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills
Experimental: SPIO 6 hours
SPIO 6 hours group will receive conventional exercise therapy with the garment on for 2 hours and worn SPIO 4 hours more in addition to 2 hour of wear during exercise therapy.
Device: SPIO

SPIO (stabilizing input pressure orthosis) 2 hours will receive conventional exercise therapy with the garment on during 2 hours. SPIO 6 hours group wore the SPIO 4 hours more in addition to 2 hours during therapy.

SPIO 6 hours group will wear the SPIO 4 hours more in addition to 2 hours during therapy.

(conventional exercises :range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills

Other: conventional exercises
range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills
Active Comparator: Control(conventional exercises)
Control group will only receive conventional exercise therapy (for two hours a day) including range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills during hospital inpatient stay throughout 2 weeks
Other: conventional exercises
range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills


Outcome Measures

Primary Outcome Measures :
  1. Sitting Assessment Scale [ Time Frame: Immediate after orthosis is worn ]
    Sitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively.

  2. Sitting Assessment Scale [ Time Frame: 2 weeks ]
    Sitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively

  3. Sitting Assessment Scale [ Time Frame: 1 month ]
    Sitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively

  4. Sitting Assessment Scale [ Time Frame: 3 months ]
    Sitting Assessment Scale was devoloped for observational assessment of posture and balance during sitting after seating interventions. The scale consists of 5 items including head control, trunk control, foot control, arm function and hand function which are assessed as follows: 1= none; 2= poor; 3= fair; 4= good). The minimum and maximum possible scores are 5 to 20 respectively


Secondary Outcome Measures :
  1. Gross Motor Function Measure-B, Sitting Dimension [ Time Frame: 2 weeks ]
    Evaluates degree of achievement of sitting as a gross motor function. Gross Motor Function Measure sitting dimension is composed of 20 items. Each tem is scored according to special instructions on GMFM Manuel with a 4-point Likert scale including 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. If it is not possible to test an item, it should be noted as not tested (NT) It assesses degree of achievement of gross motor functions rather than quality of them. Minimum score is 0 while maxium score is 60(3x20).

  2. Gross Motor Function Measure-B, Sitting Dimension [ Time Frame: 1 month ]
    Evaluates degree of achievement of sitting as a gross motor function. Gross Motor Function Measure sitting dimension is composed of 20 items. Each tem is scored according to special instructions on GMFM Manuel with a 4-point Likert scale including 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. If it is not possible to test an item, it should be noted as not tested (NT) It assesses degree of achievement of gross motor functions rather than quality of them. Minimum score is 0 while maxium score is 60(3x20).

  3. Gross Motor Function Measure-B, Sitting Dimension [ Time Frame: 3 months ]
    Evaluates degree of achievement of sitting as a gross motor function. Gross Motor Function Measure sitting dimension is composed of 20 items. Each tem is scored according to special instructions on GMFM Manuel with a 4-point Likert scale including 0 = does not initiate, 1 = initiates, 2 = partially completes, 3 = completes. If it is not possible to test an item, it should be noted as not tested (NT) It assesses degree of achievement of gross motor functions rather than quality of them. Minimum score is 0 while maxium score is 60(3x20).

  4. Box and Block Test (BBT) [ Time Frame: Immediate after orthosis is worn ]
    Evaluates gross manuel dexterity. Box and Block Test which consists of a box divided into two compartments by a partition and blocks with standardized dimensions is used to assess unilateral gross manuel dexterity. The object is instructed to transport boxes one by one from one compertmant of the box to other in 60 seconds. The object should sit on a chair with a standard height and face the box. He/she should practice for a 15 second trial period before testing. If two blocks are carried at the same time, it is counted as one. And also if the block falls on the floor after it has been carried across, it is still counted. The score is the number of boxes transferred from one compartment to other in 60 seconds.

  5. Box and Block Test (BBT) [ Time Frame: 2 weeks ]
    Evaluates gross manuel dexterity. Box and Block Test which consists of a box divided into two compartments by a partition and blocks with standardized dimensions is used to assess unilateral gross manuel dexterity. The object is instructed to transport boxes one by one from one compertmant of the box to other in 60 seconds. The object should sit on a chair with a standard height and face the box. He/she should practice for a 15 second trial period before testing. If two blocks are carried at the same time, it is counted as one. And also if the block falls on the floor after it has been carried across, it is still counted. The score is the number of boxes transferred from one compartment to other in 60 seconds.

  6. Box and Block Test (BBT) [ Time Frame: 1 month ]
    Evaluates gross manuel dexterity. Box and Block Test which consists of a box divided into two compartments by a partition and blocks with standardized dimensions is used to assess unilateral gross manuel dexterity. The object is instructed to transport boxes one by one from one compertmant of the box to other in 60 seconds. The object should sit on a chair with a standard height and face the box. He/she should practice for a 15 second trial period before testing. If two blocks are carried at the same time, it is counted as one. And also if the block falls on the floor after it has been carried across, it is still counted. The score is the number of boxes transferred from one compartment to other in 60 seconds.

  7. Box and Block Test (BBT) [ Time Frame: 3 months ]
    Evaluates gross manuel dexterity. Box and Block Test which consists of a box divided into two compartments by a partition and blocks with standardized dimensions is used to assess unilateral gross manuel dexterity. The object is instructed to transport boxes one by one from one compertmant of the box to other in 60 seconds. The object should sit on a chair with a standard height and face the box. He/she should practice for a 15 second trial period before testing. If two blocks are carried at the same time, it is counted as one. And also if the block falls on the floor after it has been carried across, it is still counted. The score is the number of boxes transferred from one compartment to other in 60 seconds.

  8. Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7) [ Time Frame: 2 weeks ]

    A non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below:

    Parent satisfaction survey

    1. SPIO vest was easy to put on/off.
    2. Child was comfartable during times the SPIO was worn.
    3. Child's sitting balance improved.
    4. Caring of the garment (cleaning vs) was easy.
    5. Child's confidence was improved.
    6. No problems about touletting occured.
    7. I wish to attend this therapy programme again.
    8. I consider attending this therapy programme in the future again.
    9. I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45).

  9. Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7) [ Time Frame: 1 month ]

    A non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below:

    Parent satisfaction survey

    1. SPIO vest was easy to put on/off.
    2. Child was comfartable during times the SPIO was worn.
    3. Child's sitting balance improved.
    4. Caring of the garment (cleaning vs) was easy.
    5. Child's confidence was improved.
    6. No problems about touletting occured.
    7. I wish to attend this therapy programme again.
    8. I consider attending this therapy programme in the future again.
    9. I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45).

  10. Parent Satisfaction Questionnaire (Sum of the Items 3,5 and 7) [ Time Frame: 3 months ]

    A non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below:

    Parent satisfaction survey

    1. SPIO vest was easy to put on/off.
    2. Child was comfartable during times the SPIO was worn.
    3. Child's sitting balance improved.
    4. Caring of the garment (cleaning vs) was easy.
    5. Child's confidence was improved.
    6. No problems about touletting occured.
    7. I wish to attend this therapy programme again.
    8. I consider attending this therapy programme in the future again.
    9. I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45).

  11. Parent Satisfaction Questionnaire Total Score [ Time Frame: 2 weeks ]

    A non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below:

    Parent satisfaction survey

    1. SPIO vest was easy to put on/off.
    2. Child was comfartable during times the SPIO was worn.
    3. Child's sitting balance improved.
    4. Caring of the garment (cleaning vs) was easy.
    5. Child's confidence was improved.
    6. No problems about touletting occured.
    7. I wish to attend this therapy programme again.
    8. I consider attending this therapy programme in the future again.
    9. I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45).

  12. Parent Satisfaction Questionnaire Total Score [ Time Frame: 1 month ]

    A non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below:

    Parent satisfaction survey

    1. SPIO vest was easy to put on/off.
    2. Child was comfartable during times the SPIO was worn.
    3. Child's sitting balance improved.
    4. Caring of the garment (cleaning vs) was easy.
    5. Child's confidence was improved.
    6. No problems about touletting occured.
    7. I wish to attend this therapy programme again.
    8. I consider attending this therapy programme in the future again.
    9. I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45).

  13. Parent Satisfaction Questionnaire Total Score [ Time Frame: 3 months ]

    A non-standardised 5-point Likert type scale was invented by the investigators to assess compliance and satisfaction with wearing orthosis. The parent satisfaction survey was measured on a 5-point Likert scale with 1 strongly agree and 5 strongly disagree to items of questionnaire below:

    Parent satisfaction survey

    1. SPIO vest was easy to put on/off.
    2. Child was comfartable during times the SPIO was worn.
    3. Child's sitting balance improved.
    4. Caring of the garment (cleaning vs) was easy.
    5. Child's confidence was improved.
    6. No problems about touletting occured.
    7. I wish to attend this therapy programme again.
    8. I consider attending this therapy programme in the future again.
    9. I consider to use SPIO vest for my child after the the therapy programme ended. Higher values representing better outcome. Items 3,5 and 7 is used to compare all groups (min 3-max 15) while the all of the items were used to compare the SPIO 2 hours and SPIO 6 hours (min 5-max 45).


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. being classified at Gross Motor Function Classification System (GMFCS) level III-IV
  2. being classified at Manual Ability Classification System (MACS) level III-IV
  3. being able to understand and execute given instructions for evaluations
  4. parental acceptance of using the lycra based compression garment.

Exclusion Criteria:

  1. serious respiratory restriction
  2. having refractory cyanosis or circulatory disorder
  3. having undergone lycra compression orthosis treatment programme previously
  4. having undergone botulinum toxin injection within last 3 months or orthopedic surgery within 1 year
  5. severe scoliosis (Cobb angle (CA) >40°)
  6. uncontrolled epilepsy
  7. having intrathecal baclofen pump
  8. having undergone selective dorsal rhizotomy
  9. having reflux more than 3 times a week.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03191552


Locations
Turkey
Marmara University School of Medicine Department of Physical Medicine and Rehabilitation
İstanbul, Turkey, 34899
Sponsors and Collaborators
Marmara University
Investigators
Principal Investigator: Esra Giray, MD Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation
Study Chair: Naime Evrim Karadag-Saygi, Prof Marmara University School of Medicine, Department of Physical Medicine and Rehabilitation
  Study Documents (Full-Text)

Documents provided by Marmara University:
Study Protocol  [PDF] October 7, 2017
Statistical Analysis Plan  [PDF] October 7, 2017
Informed Consent Form  [PDF] October 7, 2017

More Information

Publications:
How does the TherSuit® works? TheraSuit® / TheraSuit Method®. http://www.suittherapy.com/therasuit%20info.htm.
Hylton N, Schoos KK. Deep Pressure Sensory Input. SPIO Flexible Compression Bracing. http://www.spioworks.com/files/Deep%20Pressure%20Sensory%20Input%20Hylton%20Schoos.pdf; 2007.
Knox V. The use of Lycra garments in children with cerebral palsy: A report of a descriptive clinical trial. The British Journal of Occupational Therapy 2003; 66: 71-7.

Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT03191552     History of Changes
Other Study ID Numbers: 09.2013.0351
First Posted: June 19, 2017    Key Record Dates
Results First Posted: December 14, 2017
Last Update Posted: January 19, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marmara University:
Cerebral palsy
lycra garments
orthosis
suit therapy
trunk control

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases