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Completed

NCT Number: NCT03759145

The Jintronix Interactive System for Upper Extremity Rehabilitation Training Post Stroke

Stroke is a leading cause of death and disability worldwide.Hemiplegia, weakness of one side of the body, is a common consequence of stroke that can lead to significant functional impairments. Loss of arm function occurs in up to 85% of stroke survivors. The impact of arm-related limitations on activities of daily living, leisure activities or work is significant as the arm plays a central role in a person's life from the ability to perform basic activities of daily life to carrying out family and social roles. Guidelines indicate that rehabilitation can improve upper extremity (UE) motor control and functional status post stroke. Virtual reality (VR) and computer games are recent technologies that, as they become more accessible and affordable,are increasingly being used in rehabilitation to allow patients to engage in repetitive practice of specific tasks. A number of published reviews and meta-analyses have examined the use of VR and video games for post-stroke rehabilitation, focusing on or including UE rehabilitation. The authors agree that there is limited but promising findings that VR and video-games, when combined with traditional rehabilitation, have a positive impact on recovery post-stroke.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Université de Montréal

Montreal, Quebec, H3N 1X7, Canada

About this study

The goal of the study is to assess the feasibility, safety, and acceptability of the Jintronix system, as well as provide preliminary evidence regarding the clinical efficacy for post-stroke rehabilitation.This is a pilot parallel randomised single-blinded controlled trial, with patients who have had a stroke randomly allocated to one of two groups: (1) usual rehabilitation services and additional training with Jintronix system (treatment group) or (2) usual rehabilitation services only (control group).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • having had an ischemic or hemorrhagic stroke for the first time;
  • having residual mild to moderate UE impairment (score 3-6 on the Chedoke-McMaster arm component, as long as exergames can be played);
  • being in subacute stage (within 6 months post-stroke);
  • receiving usual out-patient rehabilitation services at one of the two selected rehabilitation sites, located in the greater Montreal area in Canada.

Exclusion criteria

  • being medically unstable;
  • having severe cognitive or communication deficits;
  • having visual impairments limiting use of the exergame;
  • having any medical contraindication for shoulder movements;
  • having severe balance deficits limiting sitting safely independently;
  • having previous upper limb impairment limiting potential recovery;
  • having any other impairment that limited use of the exergame.

Treatment and study plan

Exergame

Other

Participants use exergame with the therapist in the rehabilitation center. Several games are available, the therapist adjusts the choice of game and level of difficulty according to the participant's abilities and interests.

Usual Care

Other

participants continued their planned rehabilitation sessions

Primary outcomes

  1. number of sessions (feasibility)

    Time frame: 4 week period

    number of sessions the participant used the system during the study period

  2. duration of sessions

    Time frame: 4 week period (ongoing)

    the average duration of sessions (minutes)

  3. time spent by therapist assisting the participant

    Time frame: 4 week period (ongoing)

    time during the sessions that the therapist spent assisting the participant (minutes)

  4. time spent on each exergame

    Time frame: 4 week period (ongoing)

    the time spent on each exergame (minutes)

  5. adverse event (counts)

    Time frame: 4 week period (ongoing)

    occurrence of adverse events such as falls, motion sickness, dizziness and headaches

  6. adverse event (borg exertion scale, self-reported scale 6-20, (Borg Exertion Scale scored from 6-20, no exertion to maximal exertion)

    Time frame: 4 week period (ongoing)

    exertion after playing the exergame reported using the Borg Exertion Scale

  7. adverse event (pain self reported on visual analog scale 0-10)

    Time frame: 4 week period (ongoing)

    pain after playing the exergame reported using visual analog scale 0-10, 0 is no pain, 10 is the worse pain imaginable.

  8. Stroke-specific measure of quality of life - Stroke Impact Scale

    Time frame: 4 week period (per-post)

    Stroke Impact Scale is a questionnaire of the impact that the stroke is having on function, mood, emotional status, total score 0-100, with with higher scores indicating better self-reported health.

  9. upper limb function assessed using the Motor Activity Log

    Time frame: 4 week period (per-post)

    The Motor Activity Log is a questionnaire that the participant completes reporting how much the impaired upper limb is used for various daily tasks, each task is scored from 0-5 (ordinal scale, 0=do not use arm - 6=use as much as before), total score is mean of the scores.

  10. upper limb function assessed using the Box and Block test

    Time frame: 4 week period (per-post)

    upper limb function is assessed using the box and block test where participants are timed while picking up and placing wooden cubes

  11. upper limb motor control assessed using the Fugl-Meyer Assessment-upper extremity

    Time frame: 4 week period (per-post)

    Upper limb motor control is assessed using a valid and reliable outcome, measure consisting of tasks to be performed by the participant, scores between 0-66, higher scores indicating better motor control.

Sponsors and collaborators

Lead sponsor

Université de Montréal

Other

Registry information

Official study title

The Jintronix Interactive System for Upper Extremity Rehabilitation Training Post Stroke: A Pilot Study

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 29, 2018
Registry last updated
Nov 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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