RehabTouch Home Therapy for Stroke Patients

Cerebral Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503617
• Other study ID #: 1R44AG059256-01A1
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: January 2022
• Source: Flint Rehabilitation Devices, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Stroke
• Stroke

Intervention

Device:
• RehabTouch
Exercise using the motion sensing devices and a computer

Other:
• Conventional tabletop exercise program
Exercise following printed sheets of exercises

Locations

Country	Name	City	State
United States	Rancho Research Institute, Inc.	Downey	California

Sponsors (2)

Lead Sponsor	Collaborator
Flint Rehabilitation Devices, LLC	Rancho Research Institute, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Fugl-Meyer Arm Motor Score 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.	From Baseline to One-month Post-therapy
Secondary	Change in Box and Blocks Test Score	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.	From Baseline to One-month Post-therapy
Secondary	10 Meter Walk Test	The 10MWT assesses walking speed in meters per second over a short duration.	From Baseline to One-month Post-therapy
Secondary	Motor Activity Log	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.	One-month Post-therapy
Secondary	Visual Analog Pain Scale	A standard analog scale that ranges from 0 to 10 for assessing pain.	From Baseline to One-month Post-therapy
Secondary	Modified Ashworth Spasticity Scale	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.	From Baseline to One-month Post-therapy