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):
Marmara University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Cerebral Palsy
Postural; Defect
Interventions: Device: SPIO
Other: conventional exercises

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Among the 36 children evaluated for recruitment, 26 of them met the inclusion criteria. There were two drop-outs throughout the follow-up period. Finally, data from 24 children were analyzed.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Not meeting inclusion criteria (n=10)

  • Mixed CP n=2
  • Undergone surgery in past 6 months n=2
  • BTX-A injection in past 3 months n=2
  • Who do not understand and execute given instructions, severe CP n=4

Reporting Groups
  Description
SPIO(Stabilizing Pressure Input Orthosis) 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.

SPIO (stabilizing input pressure orthosis): SPIO 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

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

SPIO (Stabilizing Pressure Input Orthosis) 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.

SPIO (stabilizing input pressure orthosis): SPIO 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

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

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

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


Participant Flow:   Overall Study
    SPIO(Stabilizing Pressure Input Orthosis) 2 Hours   SPIO (Stabilizing Pressure Input Orthosis) 6 Hours   Control (Conventional Exercises)
STARTED   9   9   8 
COMPLETED   8   8   8 
NOT COMPLETED   1   1   0 
Lost to Follow-up                1                0                0 
Undergone surgery (Progressive hip dyspl                0                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
SPIO 2 Hours

SPIO 2 hours (worn SPIO 2 hours during therapy)

9 were allocated, one of them lost follow up before the assessment at 1 month and 8 completed

SPIO 6 Hours

SPIO 6 hours (worn SPIO 4 hours in addition to 2 hours of wear during therapy).

9 were allocated, one of them withdrew due to surgery for progressive hip dysplasia between the assessments at 1 month and 3 months and 8 completed.

Control (Conventional Exercises) Control group (received only conventional exercise therapy) 8 were recruited/ 8 completed the study
Total Total of all reporting groups

Baseline Measures
   SPIO 2 Hours   SPIO 6 Hours   Control (Conventional Exercises)   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   8   8   24 
Age 
[Units: Participants]
Count of Participants
       
Participants Analyzed   8   8   8   24 
<=18 years   8   8   8   24 
Between 18 and 65 years   0   0   0   0 
>=65 years   0   0   0   0 
Age 
[Units: Months]
Mean (Standard Deviation)
       
Participants Analyzed   8   8   8   24 
   64.29  (18.09)   60.5  (19.57)   55.63  (18.11)   61  (18) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Participants Analyzed   8   8   8   24 
Female      2  25.0%      1  12.5%      2  25.0%      5  20.8% 
Male      6  75.0%      7  87.5%      6  75.0%      19  79.2% 
Race and Ethnicity Not Collected [1] 
[Units: Participants]
Count of Participants
       
Participants Analyzed   0   0   0   0 
            0 
[1] Race and Ethnicity were not collected from any participant.
Cerebral palsy (CP) type 
[Units: Participants]
Count of Participants
       
Diplegic         
Participants Analyzed   8   8   8   24 
Diplegic   1   0   1   2 
Tetraplegic         
Participants Analyzed   8   8   8   24 
Tetraplegic   7   8   7   22 
GMFCS Level [1] 
[Units: Participants]
Count of Participants
       
GMFCS level 3         
Participants Analyzed   8   8   8   24 
GMFCS level 3   2   2   1   5 
GMFCS level 4         
Participants Analyzed   8   8   8   24 
GMFCS level 4   6   6   7   19 
[1]

GMFCS© Robert Palisano, Peter Rosenbaum, Stephen Walter, Dianne Russell, Ellen Wood, Barbara Galuppi, 1997. CanChild Centre for Childhood Disability Research, McMaster University. (Reference: Dev Med Child Neurol 1997;39:214-223).

Levels I-V based on self-initiated movement, with emphasis on sitting, transfers, and mobility. Level I is highest functioning, level V is lowest

General:

I: walks without limitations II: walks with limitations III: walks using hand-held mobility device IV: self-mobility with limitations; may use powered mobility V: transported in manual wheelchair



  Outcome Measures

1.  Primary:   Sitting Assessment Scale   [ Time Frame: Immediate after orthosis is worn ]

2.  Primary:   Sitting Assessment Scale   [ Time Frame: 2 weeks ]

3.  Primary:   Sitting Assessment Scale   [ Time Frame: 1 month ]

4.  Primary:   Sitting Assessment Scale   [ Time Frame: 3 months ]

5.  Secondary:   Gross Motor Function Measure-B, Sitting Dimension   [ Time Frame: 2 weeks ]

6.  Secondary:   Gross Motor Function Measure-B, Sitting Dimension   [ Time Frame: 1 month ]

7.  Secondary:   Gross Motor Function Measure-B, Sitting Dimension   [ Time Frame: 3 months ]

8.  Secondary:   Box and Block Test (BBT)   [ Time Frame: Immediate after orthosis is worn ]

9.  Secondary:   Box and Block Test (BBT)   [ Time Frame: 2 weeks ]

10.  Secondary:   Box and Block Test (BBT)   [ Time Frame: 1 month ]

11.  Secondary:   Box and Block Test (BBT)   [ Time Frame: 3 months ]

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Outcome measures assesses body structure and function only. Effects of orthosis on activity and participation were not evaluated


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Esra Giray
Organization: Department of Physical medicine and Rehabilitation, Marmara University School of Medicine, Istanbul,Turkey
phone: +90216624545 ext 6515
e-mail: girayesra@hotmail.com


Publications of Results:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT03191552     History of Changes
Other Study ID Numbers: 09.2013.0351
First Submitted: June 8, 2017
First Posted: June 19, 2017
Results First Submitted: August 9, 2017
Results First Posted: December 14, 2017
Last Update Posted: January 19, 2018