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

NCT02923167 | Completed Results FDA Device

• 1 other identifier: 2016P000926
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

CP; Cerebral Palsy; Robotic; Hand; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Change in Quality of Upper Extremity Skills Test (QUEST) Score - Section on Dissociated Movements

  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.

  Data collected at baseline and at completion of the 7-week intervention

• Change in Quality of Upper Extremity Skills Test (QUEST) Score - Section on Grasp

  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.

  Data collected at baseline and at completion of the 7-week intervention

Secondary Outcomes (6)

• 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

Study Arms (1)

Robotic-assisted training of the hand

EXPERIMENTAL

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).

Device: Robotic-assisted training of the hand

Interventions

Robotic-assisted training of the hand 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).

Also known as: Amadeo® - Tyromotion

Robotic-assisted training of the hand

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of cerebral palsy (CP) with upper-limb impairment
• to 18 years of age.
• Manual Ability Classification Scale Level II or III.
• Ability to communicate pain or discomfort.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Paolo Bonato
• Organization: Spaulding Rehabilitation Hospital

pbonato@mgh.harvard.edu

617-952-6319

Study Officials

• Paolo Bonato, PhD

  Spauding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: September 30, 2016
• First Posted: October 4, 2016
• Study Start: May 16, 2017
• Primary Completion: August 12, 2020
• Study Completion: July 7, 2021
• Last Updated: October 22, 2021
• Results First Posted: September 5, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)