Purpose

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

Eligibility

Eligible Ages
Between 9 Years and 14 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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 names:
    • Amadeo® - Tyromotion

Recruiting Locations

Spaulding Rehabilitation Hospital
Boston, Massachusetts 02129
Contact:
Catherine Adans-Dester
617-952-6321
cadans-dester@partners.org

More Details

NCT ID
NCT02923167
Status
Recruiting
Sponsor
Spaulding Rehabilitation Hospital

Study Contact

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

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.