NCT06156969

Muscle Synergies During Gait in Children With Cerebral Palsy Undergoing Robot-assisted Gait Therapy

Completed NA Results posted Last updated 19 March 2024

What this trial tests

NA trial testing Robot-Assisted Gait Training in Cerebral Palsy in 19 participants. Completed in 8 September 2020.

Timeline

20 October 2015

Primary endpoint
6 September 2018

8 September 2020

Quick facts

Lead sponsor	Spaulding Rehabilitation Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	19
Start date	20 October 2015
Primary completion	6 September 2018
Estimated completion	8 September 2020
Sites	1 location across United States

Drugs / interventions tested

• Robot-Assisted Gait Training

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 Cosine Similarity of the Muscle Synergies of the Most Affected Lower Limb Primary · Data collected at baseline and at completion of the 7-week intervention

Surface electromyographic (EMG) data collected from 16 muscles of the lower limbs during overground gait will be analyzed using the non-negative matrix factorization technique to quantify the patterns of co-activation of muscles. Cosine similarity values will be estimated for the EMG recordings collected pre- and post-intervention. Cosine similarity values will range between 0 and 1, where 1 means that the patterns of co-activation are identical to normative whereas 0 means that they are completely different (as they do not overlap). The percentage of muscle synergies displaying an increase in

Group	Value	95% CI
Robot-assisted Gait Training	2	± 6

Change in Gross Motor Function Measure (GMFM) Dimension D Secondary · Data collected at baseline and at completion of the 7-week intervention

The GMFM Dimension D consists of a battery of thirteen motor tasks that the rater evaluates via visual observation of the motor behavior of the study participant. Dimension D of the scale is focused on standing function. Each item is scored on a 4-point ordinal scale from 0 to 3, where 0 indicates that the participant does not initiate the task; 1 indicates that the participant initiates the task; 2 indicates that the participant partially completes the task; and 3 indicates that the participant completes the task. The minimum value is 0, and the maximum value is 39. Higher values represent be

Group	Value	95% CI
Robot-assisted Gait Training	5.9	± 8.1

Change in Gross Motor Function Measure (GMFM) Dimension E Secondary · Data collected at baseline and at completion of the 7-week intervention

The GMFM Dimension E consists of a battery of twenty-four motor tasks that the rater evaluates via visual observation of the motor behavior of the study participant. Dimension E of the scale is focused on walking function. Each item is scored on a 4-point ordinal scale from 0 to 3, where 0 indicates that the participant does not initiate the task; 1 indicates that the participant initiates the task; 2 indicates that the participant partially completes the task; and 3 indicates that the participant completes the task. The minimum value is 0, and the maximum value is 72. Higher values represent

Group	Value	95% CI
Robot-assisted Gait Training	10.0	± 9.3

Percent Change in 10-Meter Walk Test Secondary · Data collected at baseline and at completion of the 7-week intervention

Study staff will use a stopwatch to measure the time needed by study participants to cover a distance of 10 meters.

Group	Value	95% CI
Robot-assisted Gait Training	-0.8	± 28.0

Percent Change in 6-Minutes Walk Test Secondary · Data collected at baseline and at completion of the 7-week intervention

Study staff will measure the distance walked by study participants during an interval of 6 min.

Group	Value	95% CI
Robot-assisted Gait Training	23.5	± 37.7

Percent Change in Edinburgh Visual Gait Scores (EVGS) Secondary · Data collected at baseline and at completion of the 7-week intervention

The EVGS score is a standardized measure of gait quality derived using criteria based on visual observation of gait patterns in children with cerebral palsy. The EVGS includes 17 gait parameters and uses a three-point ordinal scale for each parameter, corresponding to normal, moderate, and severe deviation, respectively. The total score range is from 0 to 34 points, where 0 corresponds to normal gait and greater than 0 indicates gait abnormality.

Group	Value	95% CI
Robot-assisted Gait Training	16.7	± 12.7

Sponsor's own description

This is a single-arm longitudinal study for children with cerebral palsy with gait impairments that involves robot-assisted gait training (RGT) and includes pre and post-data collection visits. The study aims to evaluate changes in muscle synergies in children with Cerebral Palsy (CP) in response to RGT. Additionally, the study aims to investigate the relationship between muscle synergies and the clinical outcomes of RGT.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Can muscle synergies shed light on the mechanisms underlying motor gains in response to robot-assisted gait training in children with cerebral palsy?
   Vergara-Diaz GP, Sapienza S, Daneault JF, Fabara E, et al · · 2025 · cited 3× · PMID 39920813 · DOI 10.1186/s12984-025-01550-x