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Completed

NCT Number: NCT03503617

RehabTouch Home Therapy for Stroke Patients

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.

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Key information

Conditions

Cerebral Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rancho Research Institute, Inc.

Downey, California, 90242, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RehabTouch

Device

Exercise using the motion sensing devices and a computer

Other names: FitMi

Conventional tabletop exercise program

Other

Exercise following printed sheets of exercises

Primary outcomes

  1. Change in Fugl-Meyer Arm Motor Score From Baseline to One Month Post Therapy

    Time frame: 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 outcomes

  1. Change in Box and Blocks Test Score

    Time frame: 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.

  2. 10 Meter Walk Test

    Time frame: From Baseline to One-month Post-therapy

    The 10MWT assesses walking speed in meters per second over a short duration.

  3. Motor Activity Log

    Time frame: 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.

  4. Visual Analog Pain Scale

    Time frame: From Baseline to One-month Post-therapy

    A standard analog scale that ranges from 0 to 10 for assessing pain.

  5. Modified Ashworth Spasticity Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Flint Rehabilitation Devices, LLC

Industry

Collaborators

  • Rancho Research Institute, Inc.

Registry information

Official study title

RehabTouch: A Mixed-reality Gym for Rehabilitating the Hands, Arms, Trunk, and Legs After Stroke

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 20, 2018
Registry last updated
Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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