Clinical trial NCT05321446: GoHand(TM) to Enhance Recovery of Arm and Hand Function Post-Stroke
Official title: GoHand(TM) to Enhance Recovery of Arm and Hand Function Post-Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: recovery feedback sensors hand function movement
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Primary outcomes:
measure: Change in hand movement quality metrics from GoHand sensor.
timeFrame: Change over 1 month
Secondary outcomes:
measure: Change in Nine Hole Peg Test (NHPT)
timeFrame: Change over 1 month
measure: Change in Box and Block Test (BBT)
timeFrame: Change over 1 month
measure: Change in Grip strength
timeFrame: Change over 1 month
measure: Change in Stroke Arm Ladder (SF-ARM)
timeFrame: Change over 1 month
Other outcomes:
measure: Change in Patient Reported Outcomes
timeFrame: Change over 1 month
measure: Adherence
timeFrame: Over 1 month
measure: Change in amount of use
timeFrame: Day 1 and day 30 of home practice period
measure: Change in Two Minute Walk Test (2MWT)
timeFrame: Change over 1 month
Locations:
city: Montréal
country: Canada
facility: Research Institute of the McGill University Health Center, CORE, 5252 de Maisonneuve
state: Quebec
Study officials:
References: