RehabTouch Home Therapy for Stroke Patients

Not Applicable

Completed

• Conditions: Cerebral Stroke
• Interventions: Device: RehabTouch; Other: Conventional tabletop exercise program

• Registration Number: NCT03503617
• Lead Sponsor: Flint Rehabilitation Devices, LLC

Brief Summary

We will investigate the efficacy of a newly developed exercise device (RehabTouch) for people in the subacute stage after a stroke compared to a traditional tabletop exercise program. RehabTouch uses embedded sensors that can track and record the patient's direction and degree of movement as they perform exercises described on a computer.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-18
• Study First Posted: 2018-04-20
• Study Start: 2018-11-01
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31
• Results First Submitted: 2021-11-15
• Status Verified: 2022-01
• Results First Submitted QC: 2022-01-10
• Last Update Submitted: 2022-01-10
• Results First Posted: 2022-02-07
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Age: 18 to 85 years old
• Upper extremity weakness measured by a clinical scale
• Absence of moderate to severe pain on affected upper extremity
• Able to understand the instructions to operate RehabTouch

Exclusion Criteria

• Concurrent severe medical problems, visual deficits, severe neglect or apraxia
• Enrollment to other therapy studies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RehabTouch Exercise Program	RehabTouch	Participants will perform targetted movement exercises by interacting with the RehabTouch pucks, as described and monitored on a computer. Participants will be asked to exercise at least 3 hours per week for 3 consecutive weeks.
Conventional tabletop exercise program	Conventional tabletop exercise program	Conventional tabletop exercise program is a traditional exercise program described in a booklet similar to what is typical provided to stroke patients upon their discharge from the hospital. Participants will be asked to perform these exercises at least 3 hours per week for 3 consecutive weeks.

Primary Outcome Measures

Name	Time	Method
Change in Fugl-Meyer Arm Motor Score From Baseline to One Month Post Therapy	From Baseline to One-month Post-therapy	The Fugl-Meyer Arm Motor Score is a stroke-specific, performance-based impairment index which measure 33 arm movement patterns based on a scale of 0 to 2 each, for a total possible score of 66. For each movement patter, a score of zero means the participant is unable to perform the movement pattern; a score of 2 means the participant performed the movement patterns faultlessly.

Secondary Outcome Measures

Name	Time	Method
Change in Box and Blocks Test Score	From Baseline to One-month Post-therapy	The Box \& Blocks Test (BBT) score assess hand function and gripping ability by instructing an individual to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period.
Motor Activity Log	One-month Post-therapy	The Motor Activity Log (MAL) is a semi-structured interview to assess arm function after hemiparetic stroke. Individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during 28 daily functional tasks on a 0-5 point scale. For the QOM subscale, 0 represents an inability to use the affected arm to perform an activity, while 5 represents a normal ability to use the affected arm. For the AOM scale, 0 represents never using the affected arm to perform the activity, and 5 indicates always using the affected arm to perform the activity.
Visual Analog Pain Scale	From Baseline to One-month Post-therapy	A standard analog scale that ranges from 0 to 10 for assessing pain.
10 Meter Walk Test	From Baseline to One-month Post-therapy	The 10MWT assesses walking speed in meters per second over a short duration.
Modified Ashworth Spasticity Scale	From Baseline to One-month Post-therapy	The Modified Ashworth Spasticity (MAS) Scale measures spasticity in patients with lesions of the Central Nervous System. Tests resistance to passive movement about a joint with varying degrees of velocity, with movements in flexion and extension scored separately. Scores for each movement direction and joint range from 0-5, with 6 choices. A score of 0 indicates no increase in tone during movement. A score of 5 indicates that the limb was rigid during the passive movement.

Trial Locations

Locations (1)

Rancho Research Institute, Inc.; 🇺🇸 Downey, California, United States