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临床试验/NCT05321446
NCT05321446Unknown不适用

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

McGill University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
12
试验地点
2
主要终点
Change in hand movement quality metrics from GoHand sensor.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Device Feasibility
盲法
None

盲法说明

No masking required as outcomes are based on technology and performance tests.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Change in hand movement quality metrics from GoHand sensor.

时间窗: Change over 1 month

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.

次要结局

  • 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)
  • Change in Nine Hole Peg Test (NHPT)(Change over 1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nancy Mayo

James McGill Professor

McGill University

研究点 (2)

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