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AOT and ICT for Hemiplegia (Tele-UPCAT)

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ClinicalTrials.gov Identifier: NCT03094455
Recruitment Status : Completed
First Posted : March 29, 2017
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
BioRobotics Institute
Information provided by (Responsible Party):
IRCCS Fondazione Stella Maris

Tracking Information
First Submitted Date  ICMJE March 16, 2017
First Posted Date  ICMJE March 29, 2017
Last Update Posted Date August 7, 2019
Actual Study Start Date  ICMJE March 29, 2017
Actual Primary Completion Date October 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
Changes in the Assisting Hand Assessment [ Time Frame: Baseline (T0, 1week before beginning of Study) ;T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group), T2 and T3 (8weeks after T1 or T1/plus) T3 (16 weeks after T2) ]
This assessment measures upper limb function during bimanual activities. The test evaluates spontaneous use of assisting hand during a semi-structured session with specific toys or tasks with objects requiring bimanual handling
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2017)
  • Changes in Box and Block Test [ Time Frame: Baseline (T0, 1week before beginning of Study) ;T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group), T2 and T3 (8weeks after T1 or T1/plus) T3 (16 weeks after T2) ]
    : it measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations from childhood to adults.
  • Changes in Melbourne Assessment of Unilateral Upper Limb Function [ Time Frame: Baseline (T0, 1week before beginning of Study) ;T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group), T2 and T3 (8weeks after T1 or T1/plus) T3 (16 weeks after T2) ]
    It is criterion-referenced test that measures unilateral upper extremity quality of movement in subjects with neurological impairments
  • Changes in ABILHAND-kids [ Time Frame: Baseline (T0, 1week before beginning of Study) ;T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group), T2 and T3 (8weeks after T1 or T1/plus) T3 (16 weeks after T2) ]
    a semi-structured item-response questionnaire that measures manual ability according to an caregiver's perceived difficulty performing daily bimanual tasks.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2017)
  • Changes in Box and Block Test [ Time Frame: Baseline (T0, 1week before beginning of Study) ;T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group), T2 and T3 (8weeks after T1 or T1/plus) T3 (16 weeks after T2) ]
    : it measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations from childhood to adults.
  • Changes in Melbourne Assessment of Unilateral Upper Limb Function [ Time Frame: Baseline (T0, 1week before beginning of Study) ;T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group), T2 and T3 (8weeks after T1 or T1/plus) T3 (16 weeks after T2) ]
    It is criterion-referenced test that measures unilateral upper extremity quality of movement in subjects with neurological impairments
  • Changes in ABILHAND [ Time Frame: Baseline (T0, 1week before beginning of Study) ;T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group), T2 and T3 (8weeks after T1 or T1/plus) T3 (16 weeks after T2) ]
    a semi-structured item-response questionnaire that measures manual ability according to an individual's perceived difficulty performing daily bimanual tasks.
Current Other Pre-specified Outcome Measures
 (submitted: March 29, 2017)
  • Participation and Environment Measure - Children and Youth (PEM-CY) [ Time Frame: Baseline (T0) and T3 (16 weeks after T2) ]
    it is a measure that evaluates participation in the home, at school, and in the community, alongside environmental factors within each of these settings.
  • Cerebral Palsy Quality of Life Questionnaire [ Time Frame: Baseline (T0) and T3 (16 weeks after T2) ]
    These instruments are useful for evaluating interventions designed to improve the lives of children and adolescents
  • Quantitative measurement of reaching and grasping capabilities by means of a sensorized object that allow different grasping tasks [ Time Frame: Baseline (T0, 1week before beginning of Study) ;T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group), T2 and T3 (8weeks after T1 or T1/plus) T3 (16 weeks after T2) ]
    The sensorized object allows to perform three different tasks at increasing level of difficulties (unimanual lifting, bimanual placing near and bimanual cooperation, holding and pulling)
  • Quantitative Changes in upper limbs activities detected with Actigraph GXT3+ during AHA [ Time Frame: Baseline (T0, 1week before beginning of Study); T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group), T2 and T3 (8weeks after T1 or T1/plus) T3 (16 weeks after T2) ]
    Actigraph GXT3+ worn during AHA assessments
  • Changes in daily life activities detected with Actigraph GXT3+ [ Time Frame: During training and/or standard period (from T0 to T1 and/or T1 to T1plus) (T0,1week before beginning of Study); T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group) ]
    Quantitative measurement of daily manual activities
Original Other Pre-specified Outcome Measures
 (submitted: March 28, 2017)
  • Participation and Environment Measure - Children and Youth (PEM-CY) [ Time Frame: Baseline (T0) and T3 (16 weeks after T2) ]
    it is a measure that evaluates participation in the home, at school, and in the community, alongside environmental factors within each of these settings.
  • Cerebral Palsy Quality of Life Questionnaire [ Time Frame: Baseline (T0) and T3 (16 weeks after T2) ]
    These instruments are useful for evaluating interventions designed to improve the lives of children and adolescents
  • Quantitative measurement of reaching and grasping capabilities by means of a sensorized object that allow different grasping tasks [ Time Frame: Baseline (T0, 1week before beginning of Study) ;T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group), T2 and T3 (8weeks after T1 or T1/plus) T3 (16 weeks after T2) ]
    The sensorized object allows to perform three different tasks at increasing level of difficulties (unimanual lifting, bimanual placing near and bimanual cooperation, holding and pulling)
  • Quantitative Changes in upper limbs activities detected with Actigraph GXT3+ during AHA [ Time Frame: Baseline (T0, 1week before beginning of Study) ;T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group), T2 and T3 (8weeks after T1 or T1/plus) T3 (16 weeks after T2) ]
    Actigraph GXT3+ worn during AHA assessments
  • Changes in daily life activities detected with Actigraph GXT3+ [ Time Frame: During training and/or standard period (from T0 to T1 and/or T1 to T1plus)(T0, 1week before beginning of Study) ;T1 (within 1 week after the end of the training/control period); T1 plus (within 1 week after the end of training for waitlist group) ]
    Quantitative measurement of daily manual activities
 
Descriptive Information
Brief Title  ICMJE AOT and ICT for Hemiplegia
Official Title  ICMJE Action-Observation Therapy (AOT) and Information and Communications Technologies (ICT) for Home Rehabilitation of Hemiplegia
Brief Summary A new rehabilitative approach, called AOT, based on the recent discovery of mirror neuron system (MNS), has been used with promising results on the Upper Limb (UL) function in some studies in children with Cerebral Palsy (CP).The purpose of the present trial is to provide evidence by a RCT that AOT is an effective rehabilitation tool in Children with Unilateral CP (UCP) and that its effects are greater than standard care. Assisting Hand Assessment is chosen as primary outcome measure and a sample size of 10 per group is required. The rehabilitation lasting 3 weeks will be provided at home by an ICT platform able to deliver, manage, monitor and measure a personalized AOT.
Detailed Description

A waitlist control, evaluator-blinded, randomized trial (RCT) will be conducted according to CONSORT guidelines. Each participant will be randomized to either:

  1. Immediate intervention group (Experimental group). Children will receive immediately the system for 3 weeks.
  2. Waitlist delayed intervention (Control group). Children will continue standard care for 3 weeks and then will receive the system as the Experimental group.

As such, all participants will receive the AOT training. The system will provide an in-home, individualized, intensive treatment based on the AOT. The system will be delivered at home and the children will perform a 60-minute training session 5 days a week for 3 consecutive weeks. For the Immediate intervention group, follow-up assessment (outcome measures) will be conducted before (T0) and post-intervention at 3 weeks (T1), and then 8 and 24 weeks after T1(T2 and T3). For the Waitlist group, the assessments will be conducted before T0 and 3 weeks after (T1) the standard care, then they will follow the same timeline of the first group (T1 plus, after the AOT intervention) and 8 and 24 weeks after T1 Puls (T2 and T3). The primary endpoint will be T1. Clinical assessments will be administered by a therapist blind to group assignment in each center. Scoring of videotaped clinical outcome measures will be performed by therapists blind to group allocation and assessment order.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
It will be a parallel RCT with a waitlist design
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hemiplegia
  • Hemiplegic Cerebral Palsy
Intervention  ICMJE Other: Experimental group
Observation of video sequences showing uni¬manual or bimanual goal-directed actions followed by the execution of the observed actions either with plegic upper limb for unimanual or with both upper limbs for bimanual actions.
Other Name: AOT
Study Arms  ICMJE
  • Experimental: Experimental group
    AOT is based on the observation of meaningful actions followed by their execution
    Intervention: Other: Experimental group
  • Control group
    Children will continue standard care for 3 weeks and then will receive the AOT as the Experimental group
    Intervention: Other: Experimental group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2019)
30
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2017)
20
Actual Study Completion Date  ICMJE November 29, 2018
Actual Primary Completion Date October 29, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • confirmed diagnosis of spastic UCP
  • age between 15 and 20 years
  • predominant spasticity at upper limb upper limb
  • minimal ability to grasp and hold objects, also passively, with affected hand (House functional classification score 2 or more)
  • sufficient cooperation, cognitive and communicative understanding to perform assessments and participate in the intervention
  • subjects and parents able to commit to the intensive therapy program for a period of 3 weeks

Exclusion Criteria:

  • Children who had sustained previous orthopedic surgery or botulinum toxin A injection in the UL within 6 months prior to study entry were excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 20 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03094455
Other Study ID Numbers  ICMJE GR-2011-02350053 AOT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party IRCCS Fondazione Stella Maris
Study Sponsor  ICMJE IRCCS Fondazione Stella Maris
Collaborators  ICMJE BioRobotics Institute
Investigators  ICMJE Not Provided
PRS Account IRCCS Fondazione Stella Maris
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP