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 : June 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Device: Robotic-assisted training of the hand||Not Applicable|
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:
- 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)|
|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 :||December 2019|
|Estimated Study Completion Date :||December 2019|
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
- 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
- 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
- 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
- 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.
- 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
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
|Contact: Catherine Adans-Desteremail@example.com|
|United States, Massachusetts|
|Spaulding Rehabilitation Hospital||Recruiting|
|Boston, Massachusetts, United States, 02129|
|Contact: Catherine Adans-Dester 617-952-6321 firstname.lastname@example.org|
|Principal Investigator:||Paolo Bonato, PhD||Spauding Rehabilitation Hospital|