NCT02923167

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

Completed NA Results posted Last updated 22 October 2021

What this trial tests

NA trial testing Robotic-assisted training of the hand in Cerebral Palsy in 6 participants. Completed in 7 July 2021.

Timeline

16 May 2017

Primary endpoint
12 August 2020

7 July 2021

Quick facts

Lead sponsor	Spaulding Rehabilitation Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	16 May 2017
Primary completion	12 August 2020
Estimated completion	7 July 2021
Sites	1 location across United States

Drugs / interventions tested

• Robotic-assisted training of the hand

Conditions studied

• Cerebral Palsy — all drugs for Cerebral Palsy →

Sponsor

Spaulding Rehabilitation Hospital

Who can join

Adults 6 to 18, any sex, with Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Robotic-assisted Training of the Hand	3.5	± 4.4

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

Group	Value	95% CI
Robotic-assisted Training of the Hand	12.1	± 20.2

Change in Box and Block Test Score Secondary · Data collected at baseline and at completion of the 7-week intervention

Gross manual dexterity assessment. The test is administered by using a wooden box divided in two compartments. At the beginning of the test, 150 wooden blocks are positioned in one of these compartments. Then study participants are instructed to move, one by one, the maximum number of wooden blocks from one compartment to the other one in a time interval of 1 minute. The result of the test is the number of wooden blocks moved in 1 minute. The change from baseline to post-intervention is calculated by taking the difference between the value gathered pre-intervention and the value gathered post-

Group	Value	95% CI
Robotic-assisted Training of the Hand	1.0	± 2.0

Change in Cerebral Palsy Quality of Life Questionnaire Score - Child Secondary · Data collected at baseline, at completion of the 7-week intervention, and at one month follow-up

Questionnaire for evaluation of quality of life as reported by the child. The questionnaire covers different domains (e.g. social wellbeing and acceptance). Data is reported on a scale from 0 to 100. 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. The change from baseline to follow-up is calculated by taking the difference between the value gathered pre-intervention and the value gathered at one month follow-up.

Baseline vs post-intervention

Group	Value	95% CI
Robotic-assisted Training of the Hand	1.1	± 2.3

Baseline vs follow-up assessment

Group	Value	95% CI
Robotic-assisted Training of the Hand	2.4	± 4.1

Change in Number of Muscle Synergies Secondary · Data collected at baseline and at completion of the 7-week intervention

Subjects will be asked to reach and grasp objects of different sizes and shapes. Surface electromyographic (EMG) activity will be collected from 16 muscles of the upper-limb. EMG data is then analyzed using a mathematical technique (referred to as non-negative matrix factorization) that allows researchers to quantify patterns of co-activation among muscles. The number of muscle synergies necessary to accurately reconstruct the individual EMG channel recordings will be herein considered.

Group	Value	95% CI
Robotic-assisted Training of the Hand	0

Change in Modified Ashworth Scale Score Secondary · Data collected at baseline and at completion of the 7-week intervention

Upper extremity muscle spasticity assessment. This scale is administered by manually moving the subject's body segments and evaluate if an involuntary (reflex) response of muscles interfere with the passive movement. If testing a muscle that primarily flexes a joint, the rehabilitation specialist evaluating the subject places the joint in a maximally flexed position and moves it to a position of maximal extension over one second. If testing a muscle that primarily extends a joint, the rehabilitation specialist evaluating the subject places the joint in a maximally extended position and moves t

Group	Value	95% CI
Robotic-assisted Training of the Hand	-0.5

Change in Cerebral Palsy Quality of Life Questionnaire Score - Caregiver Secondary · Data collected at baseline, at completion of the 7-week intervention, and at one month follow-up

Questionnaire for evaluation of quality of life as reported by the caregiver. The questionnaire covers different domains (e.g. social wellbeing and acceptance). Data is reported on a scale from 0 to 100. 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. The change from baseline to follow-up is calculated by taking the difference between the value gathered pre-intervention and the value gathered at one month follow-up.

Baseline vs post-intervention

Group	Value	95% CI
Robotic-assisted Training of the Hand	4.0	± 5.1

Baseline vs follow-up assessment

Group	Value	95% CI
Robotic-assisted Training of the Hand	4.0	± 4.1

Synergy Similarity Secondary · Data collected at baseline and at completion of the 7-week intervention

Subjects will be asked to reach and grasp objects of different sizes and shapes. Surface electromyographic (EMG) activity will be collected from 16 muscles of the upper-limb. EMG data is then analyzed using a mathematical technique (referred to as non-negative matrix factorization) that allows researchers to quantify patterns of co-activation among muscles. The similarity among muscle synergies is estimated by computing the scalar product between corresponding muscle synergies. Results are reported individually for each muscle synergy. The minimum scalar product is 0 and it means that the syne

Similarity for synergy 1

Group	Value	95% CI
Robotic-assisted Training of the Hand	0.87

Similarity for synergy 2

Group	Value	95% CI
Robotic-assisted Training of the Hand	0.94

Similarity for synergy 3

Group	Value	95% CI
Robotic-assisted Training of the Hand	0.96

Similarity for synergy 4

Group	Value	95% CI
Robotic-assisted Training of the Hand	0.77

Similarity for synergy 5

Group	Value	95% CI
Robotic-assisted Training of the Hand	0.83

Adverse events — posted to ClinicalTrials.gov

Time frame: During each 1-hour session, for a total of 18 sessions over 7 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Robotic-assisted Training of the Hand

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (1 terms — click to expand)

Reaction	System	Robotic-assisted Training …
Unanticipated adverse event	General disorders	—

Data from ClinicalTrials.gov NCT02923167 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.