NCT04538326

Brief Summary

Persons post stroke executed stepping activities under four conditions: standard of care, interacting with: an off-the-shelf Microsoft-Kinect game, with a self-paced repeated custom video game and a game-paced random custom video game. Exercise intensity (neuromuscular and cardiovascular), enjoyment and perceived effort were measured during and after each condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started May 2017

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

May 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2020

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 4, 2020

Completed
Last Updated

September 4, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

April 7, 2020

Last Update Submit

August 28, 2020

Conditions

Keywords

active video gamesvirtual realityexercise intensityParkinson Disease

Outcome Measures

Primary Outcomes (5)

  • Neuromuscular intensity

    movement repetitions (stepping and marching) measured through video tape measured continuously during each exercise bout

    collected continuously during each of the four conditions. Collected in a single 2 hour session

  • Cardiovascular intensity (metabolic Units)

    metabolic units measured continuously during each exercise bout

    collected continuously during each of the four conditions. Collected in a single 2 hour session

  • Cardiovascular intensity (Percent of maximum heart rate)

    the percent of the maximum heart rate

    collected continuously during each of the four conditions. Collected in a single 2 hour session

  • Enjoyment

    measured with the PACES questionnaire after each exercise bout

    four times collected in a single 2 hour session (once at the completion of each the four conditions).

  • Borg Rate if Perceived Exertion Scale

    Measures perception of effort on a scale of 6-20

    Collected three times (at the beginning, middle and end) of each of the four exercise bouts during a single two hour session

Secondary Outcomes (2)

  • Preference ranking

    collected once at the end of the completed data collection of a 2 hour session

  • Fugl Meyer Motor Assessment Scale_ Lower Extremity Section

    collected once during the single 2 hour data collection session

Other Outcomes (1)

  • Open ended questions

    collected once during a single 2 hour data collection session

Study Arms (1)

Single

OTHER

Participants exercised in two counter balanced blocks: repeated (standard of care and self-paced repeated custom game) and random (Kinect game and game-paced random custom game). Exercise bouts were for 8.5 minutes with ten minutes of rest in between so they could return to physiological baseline. Data were collected in a single session lasting two hours.

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Participants performed stepping movements that were either cued by the investigator or interacted with a video game. There were three video game exercises that all involved stepping in either a repeated or a random pattern that was either self-paced or game paced.

Also known as: Video Game Play, Standard of Care Stepping Activities
Single

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men and women post-stroke at least six months T
  • able to ambulate 100 feet without physical assistance but allowed to use assistive devices and orthotics,
  • able to stand for 3 minutes.
  • cleared for exercise with the PARQ.

You may not qualify if:

  • history of severe heart disease, heart attack, valve replacement or coronary artery bypass surgery, severe lung disease, uncontrolled diabetes, traumatic brain injury or neurological disorder other than stroke
  • Are unable to follow directions.
  • Do not have adequate vision and hearing ability (either aided or unaided with glasses, contacts or hearing aids
  • Are unable to sign a consent form.
  • Unstable medical condition or musculoskeletal disorder such as severe arthritis, knee surgery, hip surgery, or any other condition that the investigators determine would impair the ability to perform the required stepping for the games presented.
  • Any other medical condition contraindications to exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Health Professions

Newark, New Jersey, 07011, United States

Location

Related Publications (3)

  • Kafri M, Myslinski MJ, Gade VK, Deutsch JE. Energy expenditure and exercise intensity of interactive video gaming in individuals poststroke. Neurorehabil Neural Repair. 2014 Jan;28(1):56-65. doi: 10.1177/1545968313497100. Epub 2013 Jul 29.

  • Kafri M, Myslinski MJ, Gade VK, Deutsch JE. High metabolic cost and low energy expenditure for typical motor activities among individuals in the chronic phase after stroke. J Neurol Phys Ther. 2014 Oct;38(4):226-32. doi: 10.1097/NPT.0000000000000053.

  • Deutsch JE, James-Palmer A, Damodaran H, Puh U. Comparison of neuromuscular and cardiovascular exercise intensity and enjoyment between standard of care, off-the-shelf and custom active video games for promotion of physical activity of persons post-stroke. J Neuroeng Rehabil. 2021 Apr 14;18(1):63. doi: 10.1186/s12984-021-00850-2.

MeSH Terms

Conditions

StrokeParkinson Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Judith Deutsch, PT, PhD

    Rutgers University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Participants were told that the purpose of the study was to learn more about what type of exercise they liked. There was no indication that intensity was an outcome measure.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Repeated measures, counter-balanced
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director Rivers Lab

Study Record Dates

First Submitted

April 7, 2020

First Posted

September 4, 2020

Study Start

May 1, 2017

Primary Completion

August 30, 2018

Study Completion

August 30, 2018

Last Updated

September 4, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

All IPD that underlie the results of a publication will be available through the publishers repository. We

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will be made available through the appropriate journal data sharing plan.
Access Criteria
For systematic reviews or other secondary analyses.

Locations