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

NCT05321446 | Unknown

• 1 other identifier: HBHL Ignite Program 2020
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

recovery feedback sensors hand function movement

Outcome Measures

Primary Outcomes (1)

• Change in hand movement quality metrics from GoHand sensor.

  Angular velocity wrist flexion and extension, coefficient of variation, quaterions, while doing standardized dexterity tests (wrist flexion and extension, Box and Block Test, Nine Hole Peg Test) and a set of functional tasks.

  Change over 1 month

Secondary Outcomes (4)

• Change in Nine Hole Peg Test (NHPT)

  Change over 1 month

• Change in Box and Block Test (BBT)

  Change over 1 month

• Change in Grip strength

  Change over 1 month

• Change in Stroke Arm Ladder (SF-ARM)

  Change over 1 month

Other Outcomes (4)

• Change in Patient Reported Outcomes

  Change over 1 month

• Adherence

  Over 1 month

• Change in amount of use

  Day 1 and day 30 of home practice period

Study Arms (2)

GoHand Feedback Group

EXPERIMENTAL

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.

Device: GoHand(TM)

GoHand Measurement Group

SHAM COMPARATOR

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.

Device: GoHand(TM)

Interventions

GoHand(TM) 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 Feedback Group; GoHand Measurement Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Capacity to activate the auditory feedback using the GoHand sensor.

You may not qualify if:

• Stroke more than 2 years ago
• People who get more than 2/6 items incorrect on the Six-Item Screener.
• Pain in affected arm that limits mobility and function.
• Botox in past 3 months for spasticity.
• People who do not think that they could participate in the prescribed 45 minutes per day of arm and hand activities.

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

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

Montreal, Quebec, H4A 3S5, Canada

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Nancy Mayo, PhD

CONTACT

15143862711; nancy.mayo@mcgill.ca

Ahmed Abou-Sharkh, MSc(PT)

CONTACT

ahmed.abou-sharhk@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking required as outcomes are based on technology and performance tests.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: James McGill Professor

Model Details: The intervention is positive auditory feedback provided by the device for good wrist movement during completion of different functional tasks. Two different groups are assessed, one with the device and one without in a sequential pre-post design. The groups are not compared.

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: April 11, 2022
• Study Start: July 1, 2022
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: April 11, 2022

Record last verified: 2021-10

Locations

CA (1)