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

NCT ID: NCT02923167

Last Updated: 2021-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-16
• Study Completion Date: 2021-07-07

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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's 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).

Group Type: EXPERIMENTAL

Robotic-assisted training of the hand

Intervention Type: DEVICE

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's 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).

Interventions

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's 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).

Intervention Type: DEVICE

Other Intervention Names

Amadeo® - Tyromotion

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Paolo Bonato

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paolo Bonato, PhD

Role: PRINCIPAL_INVESTIGATOR

Spauding Rehabilitation Hospital

Locations

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2016P000926

Identifier Type: -

Identifier Source: org_study_id