GoHand(TM) to Enhance Recovery of Arm and Hand Function Post-Stroke

NCT ID: NCT05321446

Last Updated: 2022-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2022-10-31

Brief Summary

This is a proof-of-concept study aimed at contributing evidence towards the need, usability and efficacy potential of the GoHandTM sensor in people with reduced hand function post-stroke. A two group, randomized, proof-of-concept, trial. The outcome is change over a one-month period in movement quality as measured by the GoHand sensor. The intervention period is one month. The intervention to be tested is the GoHand sensor, specifically the auditory feedback provided for an optimal wrist and hand movement during everyday tasks. To standardize the practice sessions, all persons will be taught the GRASP (Graded Repetitive Arm Supplementary Program) which has been shown to be of benefit to people recovering from stroke. The intervention group will practice the GRASP program with the sensor in feedback mode and the control group will practice with the sensor without feedback. The total sample size is 12, 6 per group.

The study will be used to create movement metric algorithms and provide preliminary data for extent of change and usability.

Detailed Description

Abstract One of the most frustrating and persistent motor sequelae of stroke is poor arm and hand function. There are many therapies for arm function post-stroke. The most effective strategies use repetitive, meaningful movement to promote neuroplasticity to support long lasting improvements in arm function. However, at best, the interventions are only moderately effective in improving impairment related outcomes with little or no carry over into everyday, real-world, activities.

There are two gaps in this area, one is for effective interventions and the second is for methods of measuring outcomes that reflect real-world use of the arm. This study is designed to fill both these gaps with technology. GoHandTM is conceived to be a therapeutic wearable to provide auditory feedback for any voluntary wrist and finger movement. This type of positive auditory feedback is known to stimulate neural connections and, through the process of neural plasticity, imprint the learned movement pattern. The sensor also provides performance feedback that is motivating allowing patients to set and accomplish movement and practice goals and track progress.

The global aim of this project is to develop and validate a sensing and feedback device to the detect disassociated wrist and arm movements and provide auditory feedback for hand movement over a range of starting capacities. The focus is on wrist movement because one of the strongest prognostic indicators for recovery of arm function post-stroke is 20o of active wrist extension and any degree of active finger movement.20 This is a proof-of-concept study aimed at contributing evidence towards the need, usability and efficacy potential of the GoHandTM sensor in people with reduced hand function post-stroke. People with stroke who have arm and hand movement deficits will be invited into a two group, randomized, proof-of-concept, trial. The outcome is change over a one-month period in movement quality as measured by the GoHand sensor. The intervention period is one month. The intervention to be tested is the GoHand sensor, specifically the auditory feedback provided for an optimal wrist and hand movement during everyday tasks. To standardize the practice sessions, all persons will be taught the GRASP (Graded Repetitive Arm Supplementary Program) which has been shown to be of benefit to people recovering from stroke. The intervention group will practice the GRASP program with the sensor in feedback mode and the control group will practice with the sensor without feedback. The total sample size is 12, 6 per group.

The study will be used to create movement metric algorithms and provide preliminary data for extent of change and usability.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

GoHand Feedback Group

Both groups will receive a standardized home practice program, the GRASP (Graded Repetitive Arm Supplementary Program). This is a program that has a standard set of arm and hand movements to be practiced 45 minutes per day over a one month period. The person manipulates objects to practice different hand movements. These are everyday objects and each person will be given a set of these to take home and to keep.

For the Experimental Group, the person will be taught the GRASP program and how to move the wrist and hand optimally to activate the GoHand sensor to hear the sound.

Group Type: EXPERIMENTAL

GoHand(TM)

Intervention Type: DEVICE

The GoHand(TM) is a therapeutic wearable that provides positive auditory feedback when the wrist and hand moves optimally during execution of dexterity tests and everyday movements.

GoHand Measurement Group

For Group 2, the person will be taught GRASP program and how to wear the sensor so it measures movement but does not emit a sound.

Group Type: SHAM_COMPARATOR

GoHand(TM)

Intervention Type: DEVICE

The GoHand(TM) is a therapeutic wearable that provides positive auditory feedback when the wrist and hand moves optimally during execution of dexterity tests and everyday movements.

Interventions

GoHand(TM)

The GoHand(TM) is a therapeutic wearable that provides positive auditory feedback when the wrist and hand moves optimally during execution of dexterity tests and everyday movements.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Anyone with self-reported difficulties in hand function as indicated by reporting that 2 or more items of the Stroke Impact Scale hand function domain as being somewhat or more difficult to do (as a result of the stroke and not a pre-existing arm problem)

2. Capacity to activate the auditory feedback using the GoHand sensor.

Exclusion Criteria

1. Stroke more than 2 years ago

2. People who get more than 2/6 items incorrect on the Six-Item Screener.

3. Pain in affected arm that limits mobility and function.

4. Botox in past 3 months for spasticity.

5. People who do not think that they could participate in the prescribed 45 minutes per day of arm and hand activities.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University

OTHER

Sponsor Role: lead

Responsible Party

Nancy Mayo

James McGill Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Research Institute of the McGill University Health Center, CORE, 5252 de Maisonneuve

Montreal, Quebec, Canada

Countries

Canada

Central Contacts

Nancy Mayo, PhD

Role: CONTACT

nancy.mayo@mcgill.ca

15143862711

Ahmed Abou-Sharkh, MSc(PT)

Role: CONTACT

ahmed.abou-sharhk@mail.mcgill.ca

Facility Contacts

Nancy Mayo, PhD

Role: primary

nancy.mayo@mcgill.ca

5143862711

Other Identifiers

HBHL Ignite Program 2020

Identifier Type: -

Identifier Source: org_study_id