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Computer Game-based Exercise Program Targeting Manual Dexterity for People With Spinal Cord Injury or Stroke.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05071885
Recruitment Status : Not yet recruiting
First Posted : October 8, 2021
Last Update Posted : October 8, 2021
Sponsor:
Collaborators:
First Steps Wellness Centre, Winnipeg
First Steps Wellness Centre, Regina
Information provided by (Responsible Party):
University of Manitoba

Brief Summary:

Recovery programs of the upper extremity can be extensive, for many adults with neurological disorders/injuries, including maintenance exercises that need to be done continually to maintain function and to prevent secondary disabilities. However increasing demands and shrinking funds are making it harder to meet the rehabilitation needs of Manitobans and Canadians with chronic disabilities. There is a need for innovation to improve the accessibility and engagement of rehabilitation programs for adults with upper extremity (UE) motor impairments due to spinal cord and acquired brain injuries.

The purpose of this research proposal is the further development and validation of a multipurpose plug-n-play rehab gaming system for use in community centers, in particular, at First Step Wellness center. It's no sleight of hand our gaming system provides a basis for repetitive, task-specific therapy focused on manual dexterity; object handling and manipulation for adults with spinal cord and acquired brain injuries. It was designed to transition engaging, highly effective and personalized rehabilitation programs to function in community centers , and with automated monitoring (tele monitoring), which to manage and progress outreach programs.

The gaming system consist of hardware and software components the hardware includes a low-cost, portable smart exercise manipulanduu device (EMD), with assistive technology. The EMD is designed as a HID compliant plug-n-play computer input device that emulates a standard optical computer mouse. Therefore these devices can be used with most any common/ modern computer video game that function by mouse control. Inclusion of "fun" gaming elements is intended to provide extra motivation for the patients in the form of a challenge and a more enjoyable means of encouraging them to follow tedious, repetitive movements that are often a part of the rehabilitation process. Therapeutic value can be derived from both the types of object manipulation tasks (use of the EMD), as well as the choice of computer games. Many inexpensive and readily available common computer games exist that require different levels of movement amplitude, speeds, accuracy repetition, cognitive enhancements, and offer sufficient diversity to appeal to a broad range of individual preferences (both children and adults).

A purpose-built Rehabilitation game (RTP game) has also been developed and validated. It was designed to gather event data and synchronize it with patient movements while they practice a range of game-based exercises with the hand and arm. This will provide; a) automated monitoring, assessment embedded into treatment, b) Immediate feedback to client, and c) electronic outcome measures to quantify and track client's performance over time Clinical support of outreach programs with protocols that can be easily updated will help create better-targeted and personalized solutions for patients and achieve the desired rehabilitation outcomes.

The innovation of this approach comes from the implementation of well-designed, yet inexpensive and easy-to-use hardware and computer software (i.e. in essence a computer mouse and a computer game). It can be judged in terms of the fact that the proposed system would provide highly effective exercise programs with embedded assessment and timely feedback/support for use in community centers and ultimately the home (tele rehabilitation). This research will contribute to the development and validation of promising, new technologies that have he capacity to become widely adopted as a viable, affordable eHealth tool that will support the quality of life and participation of Canadians living with chronic disabilities.


Condition or disease Intervention/treatment Phase
Stroke, Spinal Cord Injury Other: games based exercise Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Game-based Exercise program
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Computer Game-based Exercise Program Targeting Manual Dexterity for People With Spinal Cord Injury or Stroke.
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : August 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Game-based Exercise program

Each exercise session would last 45 minutes and supervised by study staff at First Step Wellness center you will be shown how to handle and move the joystick and how to play a group of computer games. The game activities will require you to move the joystick at various speeds, movement' amplitudes and in different directions. Each game will be played for 2-3 minutes.

A variety of therapy" handles of different shapes and sizes have been produced that Snap-On to joystick handle. These are designed to practice a broad range of manual dexterity skills involving the thumb, fingers, wrist and elbow, o Different games will also be used to vary the movement types and precision levels. To note you will be able to choose the types of movement exercises and games to use.

Other: games based exercise
Range of motion and strengthening exercises
Other Name: conventional exercise

Active Comparator: Range of motion and Strength Exercise program.

This will involve stretching, range of motion and strength exercises as set out by training staff at the First Step Wellness center.

On completion of the ten week exercise program, you will be invited to take part in a 30-minute interview to discuss the experiences you had on receiving the specific hand exercise program. The whole interview session will be audio taped. Your identity will be protected and your privacy will be maintained. All the information discussed and shared during the interview will be kept confidential and safely protected.

Other: games based exercise
Range of motion and strengthening exercises
Other Name: conventional exercise




Primary Outcome Measures :
  1. Computer game-based Upper Extremity (CUE) assessment of manual dexterity [ Time Frame: 10 weeks ]
    goal attainment average of several game events

  2. Wolf motor function test (WMFT) [ Time Frame: 10 weeks ]
    Upper extremity motor ability



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion criteria will include:

    1. Age 20-70, year
    2. six months following a stroke or SCI Less than two hears following a stroke of SCI
    3. Actively extend at least ten degrees at the metacarpophalangeal and interphalangeal joints, extend ten degrees at the wrist and had at least 30 degrees of active flexion-extension of the elbow and shoulder.
    4. Adequate vision to see the required images on a standard computer monitor. E) Able to provide informed consent

      Exclusion Criteria:

    1. excessive spasticity (grade three and above on the Ashworth scale) (11),
    2. any significant cognitive impairment (Montreal Cognitive Assessment scores less than 25) (12)
    3. Any other neurological disorder with the exception of a single stroke prior to testing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05071885


Contacts
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Contact: Tony Szturm, PhD 204 787 4794 tony.szturm@umanitoba.ca
Contact: Anuprita Kanitkar, PhD 2048813112 anuprita.kan@gmail.com

Sponsors and Collaborators
University of Manitoba
First Steps Wellness Centre, Winnipeg
First Steps Wellness Centre, Regina
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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT05071885    
Other Study ID Numbers: HS25163 (H2021:335)
First Posted: October 8, 2021    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Spinal Cord Injuries
Wounds and Injuries
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Spinal Cord Diseases
Trauma, Nervous System