NCT03619772

Brief Summary

Evaluation of a new EMG controlled game to improve hand function in chronic stroke survivors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 3, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

March 20, 2026

Completed
Last Updated

March 20, 2026

Status Verified

October 1, 2023

Enrollment Period

2.3 years

First QC Date

August 3, 2018

Results QC Date

October 16, 2023

Last Update Submit

March 18, 2026

Conditions

Keywords

handstroketherapyrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change in Mean Completion Time for Timed Test

    Time to complete movement to 16 randomized targets

    Baseline and 3 weeks (immediately post intervention)

Study Arms (2)

Bilateral

EXPERIMENTAL

Participants will control game using EMG from both upper limbs.

Other: Bilateral

Unilateral

ACTIVE COMPARATOR

Participants will control game using the more impaired upper limb.

Other: Unilateral

Interventions

Participants will control game using EMG from both upper limbs.

Bilateral

Participants will control game using EMG from the more impaired upper limb.

Unilateral

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Single, unilateral stroke at least 6 months prior to enrollment
  • Moderate hand impairment defined by Stage 4 or Stage 5 on the Chedoke McMaster Stroke Assessment Scale

You may not qualify if:

  • Visual neglect or deficits (with inability to compensate)
  • Upper extremity orthopedic conditions that interfere with movement
  • Cerebellar stroke
  • Children, prisoners, or adult unable to provide consent will not be recruited. As the procedures pose no increased risk for pregnant women, we will not specifically exclude them.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Seo NJ, Barry A, Ghassemi M, Triandafilou KM, Stoykov ME, Vidakovic L, Roth E, Kamper DG. Use of an EMG-Controlled Game as a Therapeutic Tool to Retrain Hand Muscle Activation Patterns Following Stroke: A Pilot Study. J Neurol Phys Ther. 2022 Jul 1;46(3):198-205. doi: 10.1097/NPT.0000000000000398. Epub 2022 Mar 22.

MeSH Terms

Conditions

StrokeMuscle WeaknessAtaxia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsDyskinesias

Results Point of Contact

Title
Alexander Barry
Organization
Shirley Ryan AbilityLab

Study Officials

  • Elliot Roth, MD

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

August 3, 2018

First Posted

August 8, 2018

Study Start

June 28, 2018

Primary Completion

October 31, 2020

Study Completion

July 1, 2023

Last Updated

March 20, 2026

Results First Posted

March 20, 2026

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations