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Robotic-assisted Therapy to Improve Manual Dexterity in Children With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT02923167
Recruitment Status : Recruiting
First Posted : October 4, 2016
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Paolo Bonato, Spaulding Rehabilitation Hospital

Brief Summary:
This is an intervention study including a baseline data collection, 6 weeks of a training intervention with robotic-assisted manual training and a post-intervention data collection. The study will be conducted in the Motion Analysis Laboratory at Spaulding Rehabilitation Hospital, Boston, MA.This study aims to assess the effectiveness of a robot-assisted training on hand function and quality of life in children with cerebral palsy. Additionally, the investigators will study the relationship between muscle synergies and the outcomes of robot-assisted training.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Device: Robotic-assisted training of the hand Not Applicable

Detailed Description:

Participants will be assessed 2 times - before and after training with the robot. All the testing and training will be done at Spaulding Rehabilitation Hospital and will include:

Clinical tests:

  • A physical examination where the investigators will measure of range of motion and muscular strength for the shoulder, elbow, forearm, wrist, and fingers of the participant.
  • A test to assess spasticity at the shoulder; elbow; forearm, and wrist.
  • A test to evaluate movement range, accuracy, dexterity and fluency during specific tasks.
  • A test to assess unilateral gross manual dexterity.
  • A test to assess quality of life (social wellbeing and acceptance, feelings about functioning, participation and physical health, emotional wellbeing and self-esteem, access to service, pain and impact of disability, and family health).

Muscle activity tests:

• A test to get detailed measures of how well participant can perform movements. The measures collected will include the movements of fingers, hands, and arms while picking up different objects. This is done by attaching small reflective markers to fingers, hands, and arms of the participant and special cameras in the room will film the movement of the markers. Special sensors (called EMG) will be attached to hands and arms to tell the investigators when muscles turn on and off while moving.

Training with the Robot:

18 times - up to 4 times per week within 7 weeks. The training will be done with a trained study staff. The robot will provide help do the movements while the participant moves their fingers to control computer games. The assistance provided by the robot will be adjusted to the ability of the participant to use their hand. Each training session will last about 1 hour. This will include about 20 minutes for stretching, setup, and warm-up. Rest breaks should be requested whenever needed. The investigators will closely monitor subject while testing.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robotic-assisted Therapy to Improve Manual Dexterity in Children With Cerebral Palsy: a Pilot Study on Clinical Outcomes and Muscle Synergies as a Possible Predictor of Response
Actual Study Start Date : May 16, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Robotic-assisted training of the hand
Training will be performed using the Amadeo®. The computer-controlled device maintains participants' forearm in a secure position using Velcro straps. Each training session will include 30 minutes of active movements that can be divided into up to 3 bouts of 10 minutes depending on particpant fatigue. Training will take place up to 4 times per week for a total of 18 sessions over up to 7 weeks. Sessions will last approximately 60 minutes (including setup, training, and rest between each bout).
Device: Robotic-assisted training of the hand
Training will be performed using the Amadeo®. The computer-controlled device maintains participants' forearm in a secure position using Velcro straps. Each training session will include 30 minutes of active movements that can be divided into up to 3 bouts of 10 minutes depending on participant fatigue. Training will take place up to 4 times per week for a total of 18 sessions over up to 7 weeks. Sessions will last approximately 60 minutes (including setup, training, and rest between each bout).
Other Name: Amadeo® - Tyromotion




Primary Outcome Measures :
  1. The Melbourne Assessment of Unilateral Limb Function [ Time Frame: Changes from baseline Melbourne Assessment of Unilateral Limb Function scores at 6 weeks and at one month follow-up ]
    Upper extremity function assessment


Secondary Outcome Measures :
  1. Box and block test [ Time Frame: Changes from baseline Box and block test scores at 6 weeks and at one month follow-up ]
    Gross manual dexterity assessment

  2. cerebral palsy Quality of Life Questionnaire [ Time Frame: Changes from baseline cerebral palsy Quality of Life Questionnaire scores at 6 weeks and at one month follow-up ]
    Questionnaire for evaluation of quality of life

  3. Analyze of muscle synergies activation [ Time Frame: Changes from baseline muscle synergies activation at 6 weeks and at one month follow-up ]
    Subjects will be asked to reach and grasp objects of different sizes and shapes. Surface electromyographic (SEMG) activity will be collected from 16 muscles of the upper-limb.

  4. Modified Ashworth Scale [ Time Frame: Changes from baseline Modified Ashworth Scale scores at 6 weeks and at one month follow-up ]
    Upper extremity muscles spasticity assessment



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of CP with upper-limb impairment
  • 9 to 14 years of age.
  • Manual Ability Classification Scale Level II or III.
  • Ability to communicate pain or discomfort.

Exclusion Criteria:

  • Recent use of upper-limb robotic-assisted training within the last 3 months.
  • Contraindication to robotic-assisted manual training such acute and pronounced pain symptoms despite conventional pain therapy of the upper-limb, lack of compliance, high-grade ataxia, advanced osteoporosis, and fractures of the upper-limb.
  • Modified Ashworth Scale (MAS) of 4 in the upper-limb.

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): NCT02923167


Contacts
Contact: Catherine Adans-Dester 617-952-6321 cadans-dester@partners.org

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Boston, Massachusetts, United States, 02129
Contact: Catherine Adans-Dester    617-952-6321    cadans-dester@partners.org   
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Investigators
Principal Investigator: Paolo Bonato, PhD Spauding Rehabilitation Hospital

Responsible Party: Paolo Bonato, PhD, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT02923167     History of Changes
Other Study ID Numbers: 2016P000926
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will not be shared.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Paolo Bonato, Spaulding Rehabilitation Hospital:
CP
Cerebral Palsy
Robotic
Hand
Rehabilitation

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