N/A N=6 Treatment

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

Cerebral Palsy

Bottom Line

View on ClinicalTrials.gov: NCT02923167 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2021

Primary outcome: Primary: Change in Quality of Upper Extremity Skills Test (QUEST) Score - Section on Dissociated Movements — 3.5 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Robotic-assisted training of the hand (Device)
Age: Pediatric, Adult · 6+ yrs
Sex: All
Sponsor: Spaulding Rehabilitation Hospital
Primary completion: Aug 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Quality of Upper Extremity Skills Test (QUEST) Score - Section on Dissociated Movements	3.5	—
PRIMARY Change in Quality of Upper Extremity Skills Test (QUEST) Score - Section on Grasp	12.1	—
SECONDARY Change in Box and Block Test Score	1.0	—
SECONDARY Change in Cerebral Palsy Quality of Life Questionnaire Score - Child	1.1; 2.4	—
SECONDARY Change in Number of Muscle Synergies	—	—
SECONDARY Change in Modified Ashworth Scale Score	-0.5	—
SECONDARY Change in Cerebral Palsy Quality of Life Questionnaire Score - Caregiver	4.0; 4.0	—
SECONDARY Synergy Similarity	0.87; 0.94; 0.96; 0.77; 0.83	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02923167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.