Cerebral Stroke
Conditions
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.
Interventions
DEVICERehabTouch
Exercise using the motion sensing devices and a computer
OTHERConventional tabletop exercise program
Exercise following printed sheets of exercises
Sponsors
Rancho Research Institute, Inc.
Flint Rehabilitation Devices, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 10 Meter Walk Test | From Baseline to One-month Post-therapy | The 10MWT assesses walking speed in meters per second over a short duration. |
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| RehabTouch Exercise Program 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.
RehabTouch: Exercise using the motion sensing devices and a computer | 14 |
| 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.
Conventional tabletop exercise program: Exercise following printed sheets of exercises | 13 |
| Total | 27 |
Baseline characteristics
| Characteristic | RehabTouch Exercise Program | Total | Conventional Tabletop Exercise Program |
|---|---|---|---|
| Age, Continuous | 50 Years STANDARD_DEVIATION 11 | 52 Years STANDARD_DEVIATION 10 | 52 Years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 18 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 9 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 18 Participants | 8 Participants |
| Race (NIH/OMB) White | 1 Participants | 3 Participants | 2 Participants |
| Region of Enrollment United States | 14 participants | 27 participants | 13 participants |
| Sex: Female, Male Female | 0 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 14 Participants | 23 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 13 |
| other Total, other adverse events | 0 / 14 | 0 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 |
Outcome results
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.
Time frame: From Baseline to One-month Post-therapy
Population: Three participants in the conventional therapy group did not perform their one-month follow-up assessment; one of these did perform the end-of-therapy assessment. For this one participant, the missing one-month follow-up data point was imputed for the primary outcome measure by adding the average change in Fugl-Meyer score across all participants in the conventional therapy group from end-of-therapy to one-month follow-up to this participant's end-of-therapy Fugl-Meyer score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RehabTouch Exercise Program | Change in Fugl-Meyer Arm Motor Score From Baseline to One Month Post Therapy | 8.0 Score on a Scale | Standard Deviation 4.6 |
| Conventional Tabletop Exercise Program | Change in Fugl-Meyer Arm Motor Score From Baseline to One Month Post Therapy | 3.1 Score on a Scale | Standard Deviation 6.1 |
p-value: 0.03t-test, 2 sided
Secondary
10 Meter Walk Test
The 10MWT assesses walking speed in meters per second over a short duration.
Time frame: From Baseline to One-month Post-therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RehabTouch Exercise Program | 10 Meter Walk Test | 1.06 meters per second | Standard Deviation 0.41 |
| Conventional Tabletop Exercise Program | 10 Meter Walk Test | 1.07 meters per second | Standard Deviation 0.39 |
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.
Time frame: From Baseline to One-month Post-therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RehabTouch Exercise Program | Change in Box and Blocks Test Score | 31.1 Boxes | Standard Deviation 20.2 |
| Conventional Tabletop Exercise Program | Change in Box and Blocks Test Score | 27.1 Boxes | Standard Deviation 16.9 |
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.
Time frame: From Baseline to One-month Post-therapy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RehabTouch Exercise Program | Modified Ashworth Spasticity Scale | Extension | 0.42 Score on a Scale | Standard Deviation 0.7 |
| RehabTouch Exercise Program | Modified Ashworth Spasticity Scale | Flexion | 2.5 Score on a Scale | Standard Deviation 2.1 |
| Conventional Tabletop Exercise Program | Modified Ashworth Spasticity Scale | Extension | 0.63 Score on a Scale | Standard Deviation 0.92 |
| Conventional Tabletop Exercise Program | Modified Ashworth Spasticity Scale | Flexion | 2.1 Score on a Scale | Standard Deviation 2.3 |
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.
Time frame: One-month Post-therapy
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| RehabTouch Exercise Program | Motor Activity Log | Amount of Use | 3.11 Score on a Scale | Standard Deviation 1.14 |
| RehabTouch Exercise Program | Motor Activity Log | How Well | 3.01 Score on a Scale | Standard Deviation 1.26 |
| Conventional Tabletop Exercise Program | Motor Activity Log | Amount of Use | 2.72 Score on a Scale | Standard Deviation 1.65 |
| Conventional Tabletop Exercise Program | Motor Activity Log | How Well | 2.50 Score on a Scale | Standard Deviation 1.53 |
Secondary
Visual Analog Pain Scale
A standard analog scale that ranges from 0 to 10 for assessing pain.
Time frame: From Baseline to One-month Post-therapy
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RehabTouch Exercise Program | Visual Analog Pain Scale | 2.5 Score on a Scale | Standard Deviation 2.3 |
| Conventional Tabletop Exercise Program | Visual Analog Pain Scale | 4.6 Score on a Scale | Standard Deviation 3.1 |