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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hemiplegia Hemiplegic Cerebral Palsy Other: Experimental group Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Official Title: Action-Observation Therapy (AOT) and Information and Communications Technologies (ICT) for Home Rehabilitation of Hemiplegia
Actual Study Start Date : March 29, 2017
Actual Primary Completion Date : October 29, 2018
Actual Study Completion Date : November 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cerebral Palsy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental group
AOT is based on the observation of meaningful actions followed by their execution
 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
Control group
Children will continue standard care for 3 weeks and then will receive the AOT as the Experimental group
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.


Other Outcome Measures:
  1. 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.

  2. 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

  3. 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)

  4. 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

  5. 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


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT03094455


Locations
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Italy
IRCCS Stella Maris Foundation
Calambrone, Pisa, Italy, 56128
Sponsors and Collaborators
IRCCS Fondazione Stella Maris
BioRobotics Institute
More Information
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Publications:

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

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Responsible Party: IRCCS Fondazione Stella Maris
ClinicalTrials.gov Identifier: NCT03094455    
Other Study ID Numbers: GR-2011-02350053 AOT
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by IRCCS Fondazione Stella Maris:
Tele-rehabilitation
Action Observation
Mirror neurons
ICT
Additional relevant MeSH terms:
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Cerebral Palsy
Hemiplegia
Brain Damage, Chronic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Paralysis
Neurologic Manifestations