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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebral Palsy
- Sponsor
- Spaulding Rehabilitation Hospital
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Change in Quality of Upper Extremity Skills Test (QUEST) Score - Section on Dissociated Movements
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This is an intervention study including a baseline data collection, 6 weeks of robot-assisted training targeting hand dexterity, 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 dexterity 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.
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 during which the investigators will measure range of motion and muscular strength at the shoulder, elbow, forearm, wrist, and fingers. * A test to assess spasticity at the shoulder, elbow, forearm, and wrist. * A test to evaluate upper extremity function. * 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. Movements will be tracked by attaching small reflective markers to the fingers, hands, and arms of the participant. Special cameras will be used to collect data. Special sensors (called electromyographic - EMG - sensors) will be attached to the hands and arms to tell the investigators when and how muscles are recruited to generate the movements. Training with the Robot: Study participants will undergo robot-assisted training for 18 times - up to 4 times per week during a period of approximately 7 weeks. The training sessions will be carried out by trained study staff. The robot will assist study participants to perform the movements while they attempt to move their fingers to control computer games. The assistance provided by the robot will be adjusted to the ability of each participant to move their hand. Each training session will last about 1 hour. This will include about 20 minutes of stretching exercises, setup time, and warm-up exercises. Study participants will be encouraged to ask for rest breaks whenever needed. The investigators will closely monitor study participants during all study sessions.
Investigators
Paolo Bonato
PhD
Spaulding Rehabilitation Hospital
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of cerebral palsy (CP) with upper-limb impairment
- •6 to 18 years of age.
- •Manual Ability Classification Scale Level II or III.
- •Ability to communicate pain or discomfort.
Exclusion Criteria
- •Use of upper-limb robotics for motor 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.
Outcomes
Primary Outcomes
Change in Quality of Upper Extremity Skills Test (QUEST) Score - Section on Dissociated Movements
Time Frame: Data collected at baseline and at completion of the 7-week intervention
Upper extremity function assessment (section on dissociated movements). The QUEST is a tool that evaluates the quality of upper extremity function. Data is reported on a scale from 0 to 100 for each assessment. The change from baseline to post-intervention is calculated by taking the difference between the value gathered pre-intervention and the value gathered post-intervention.
Change in Quality of Upper Extremity Skills Test (QUEST) Score - Section on Grasp
Time Frame: Data collected at baseline and at completion of the 7-week intervention
Upper extremity function assessment (section on grasp). The QUEST is a tool that evaluates the quality of upper extremity function. Data is reported on a scale from 0 to 100 for each assessment. The change from baseline to post-intervention is calculated by taking the difference between the value gathered pre-intervention and the value gathered post-intervention.
Secondary Outcomes
- Change in Box and Block Test Score(Data collected at baseline and at completion of the 7-week intervention)
- Change in Cerebral Palsy Quality of Life Questionnaire Score - Child(Data collected at baseline, at completion of the 7-week intervention, and at one month follow-up)
- Change in Number of Muscle Synergies(Data collected at baseline and at completion of the 7-week intervention)
- Change in Modified Ashworth Scale Score(Data collected at baseline and at completion of the 7-week intervention)
- Change in Cerebral Palsy Quality of Life Questionnaire Score - Caregiver(Data collected at baseline, at completion of the 7-week intervention, and at one month follow-up)
- Synergy Similarity(Data collected at baseline and at completion of the 7-week intervention)