Trial Outcomes & Findings for Passive Tactile Stimulation for Stroke Rehabilitation (NCT NCT03814889)

Last Updated: 2024-04-08

Results Overview

Modified Ashworth Scale (from https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale). Lower Modified Ashworth scale values indicate a better outcome. Measures spastic hypertonia by manually moving an affected joint at set velocities. Scores: 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension

Recruitment status

COMPLETED

Study phase

Target enrollment

35 participants

Primary outcome timeframe

Change from Baseline Modified Ashworth at 12 weeks

Results posted on

2024-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	Acute Stimulation: Vibration Pattern 1-3 and Sham Control All participants try on several wearable prototypes in our laboratory that provide vibration to the arm. Sensors or electrodes taped onto the arm and hand will sense muscle activity and record any changes during periods of vibration and periods with vibration turned off.	Longitudinal Stimulation: Vibration Pattern 4 1\) If the patient gets Botox injections in their hand and arm, their arm function will be measured for three months during this standard care. 2) Next, all patients will be given a wearable device to take home. The patient will wear the device while feeling vibrations for 3 hours during the day while awake for two months. During this time and 1 month after this intervention, arm function will be tested.
Acute Testing STARTED	14	0
Acute Testing COMPLETED	14	0
Acute Testing NOT COMPLETED	0	0
Longitudinal Testing STARTED	0	21
Longitudinal Testing COMPLETED	0	20
Longitudinal Testing NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Passive Tactile Stimulation for Stroke Rehabilitation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acute Stimulation: Vibration Patterns 1-3 and Sham Control n=14 Participants All participants try on several wearable prototypes in our laboratory that provide vibration to the arm. Sensors or electrodes taped onto the arm and hand will sense muscle activity and record any changes during periods of vibration and periods with vibration turned off.	Longitudinal Stimulation: Vibration Pattern 4 n=21 Participants 1\) If the patient gets Botox injections in their hand and arm, their arm function will be measured for three months during this standard care. 2) Next, all patients will be given a wearable device to take home. The patient will wear the device while feeling vibrations for 3 hours during the day while awake for two months. During this time and 1 month after this intervention, arm function will be tested.	Total n=35 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 10.3 • n=5 Participants	54.4 years STANDARD_DEVIATION 13.2 • n=7 Participants	56.8 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	14 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	20 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	21 participants n=7 Participants	35 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from Baseline Modified Ashworth at 12 weeks

Population: This measure was conducted on only one group.

Outcome measures

Outcome measures
Measure	Acute Stimulation: Vibration Patterns 1-3 and Sham Control All participants try on several wearable prototypes in our laboratory that provide vibration to the arm. Sensors or electrodes taped onto the arm and hand will sense muscle activity and record any changes during periods of vibration and periods with vibration turned off.	Longitudinal Stimulation: Vibration Pattern 4 n=20 Participants 1\) If the patient gets Botox injections in their hand and arm, their arm function will be measured for three months during this standard care. 2) Next, all patients will be given a wearable device to take home. The patient will wear the device while feeling vibrations for 3 hours during the day while awake for two months. During this time and 1 month after this intervention, arm function will be tested.
Change in Modified Ashworth at 12 Weeks	—	1.1 units on a scale Standard Error 0.22

PRIMARY outcome

Timeframe: Change from Baseline Modified Ashworth at 8 weeks

Population: This measure was conducted on only one group.

Modified Ashworth Scale (from https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale) Lower Modified Ashworth scale values indicate a better outcome. Measures spastic hypertonia by manually moving an affected joint at set velocities. Scores: 0 (0) - No increase in muscle tone 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement) 2 (3) - More marked increase in musce tone through most of the ROM, but affect part(s) easily moved 3 (4) - Considerable increase in muscle tone passive, movement difficult 4 (5) - Affected part(s) rigid in flexion or extension

Outcome measures

Outcome measures
Measure	Acute Stimulation: Vibration Patterns 1-3 and Sham Control All participants try on several wearable prototypes in our laboratory that provide vibration to the arm. Sensors or electrodes taped onto the arm and hand will sense muscle activity and record any changes during periods of vibration and periods with vibration turned off.	Longitudinal Stimulation: Vibration Pattern 4 n=20 Participants 1\) If the patient gets Botox injections in their hand and arm, their arm function will be measured for three months during this standard care. 2) Next, all patients will be given a wearable device to take home. The patient will wear the device while feeling vibrations for 3 hours during the day while awake for two months. During this time and 1 month after this intervention, arm function will be tested.
Change in Modified Ashworth at 8 Weeks	—	0.9 units on a scale Standard Error 0.28

PRIMARY outcome

Timeframe: Change from Baseline Range of Motion at 8 weeks

Population: This measure was conducted on only one group.

Finger extension range.

Outcome measures

Outcome measures
Measure	Acute Stimulation: Vibration Patterns 1-3 and Sham Control All participants try on several wearable prototypes in our laboratory that provide vibration to the arm. Sensors or electrodes taped onto the arm and hand will sense muscle activity and record any changes during periods of vibration and periods with vibration turned off.	Longitudinal Stimulation: Vibration Pattern 4 n=20 Participants 1\) If the patient gets Botox injections in their hand and arm, their arm function will be measured for three months during this standard care. 2) Next, all patients will be given a wearable device to take home. The patient will wear the device while feeling vibrations for 3 hours during the day while awake for two months. During this time and 1 month after this intervention, arm function will be tested.
Change in Range of Motion at 8 Weeks	—	11.6 degrees of finger extension Standard Error 5.2

PRIMARY outcome

Timeframe: Change from Baseline Range of Motion at 12 weeks

Population: This measure was conducted on only one group.

Finger extension range.

Outcome measures

Outcome measures
Measure	Acute Stimulation: Vibration Patterns 1-3 and Sham Control All participants try on several wearable prototypes in our laboratory that provide vibration to the arm. Sensors or electrodes taped onto the arm and hand will sense muscle activity and record any changes during periods of vibration and periods with vibration turned off.	Longitudinal Stimulation: Vibration Pattern 4 n=20 Participants 1\) If the patient gets Botox injections in their hand and arm, their arm function will be measured for three months during this standard care. 2) Next, all patients will be given a wearable device to take home. The patient will wear the device while feeling vibrations for 3 hours during the day while awake for two months. During this time and 1 month after this intervention, arm function will be tested.
Change in Range of Motion at 12 Weeks	—	18.4 degrees of finger extension Standard Error 4.3

PRIMARY outcome

Timeframe: 20 minutes after stimulation start

Population: This measure was only taken for one group of patients.

Outcome measures

Outcome measures
Measure	Acute Stimulation: Vibration Patterns 1-3 and Sham Control n=14 Participants All participants try on several wearable prototypes in our laboratory that provide vibration to the arm. Sensors or electrodes taped onto the arm and hand will sense muscle activity and record any changes during periods of vibration and periods with vibration turned off.	Longitudinal Stimulation: Vibration Pattern 4 1\) If the patient gets Botox injections in their hand and arm, their arm function will be measured for three months during this standard care. 2) Next, all patients will be given a wearable device to take home. The patient will wear the device while feeling vibrations for 3 hours during the day while awake for two months. During this time and 1 month after this intervention, arm function will be tested.
Change in Modified Ashworth During Stimulation (Pattern 1).	0.39 units on a scale Standard Deviation 0.96	—

PRIMARY outcome

Timeframe: 20 minutes after stimulation start

Population: This measure was only taken for one group of patients.

Outcome measures

Outcome measures
Measure	Acute Stimulation: Vibration Patterns 1-3 and Sham Control n=14 Participants All participants try on several wearable prototypes in our laboratory that provide vibration to the arm. Sensors or electrodes taped onto the arm and hand will sense muscle activity and record any changes during periods of vibration and periods with vibration turned off.	Longitudinal Stimulation: Vibration Pattern 4 1\) If the patient gets Botox injections in their hand and arm, their arm function will be measured for three months during this standard care. 2) Next, all patients will be given a wearable device to take home. The patient will wear the device while feeling vibrations for 3 hours during the day while awake for two months. During this time and 1 month after this intervention, arm function will be tested.
Change in Modified Ashworth During Stimulation (Pattern 2).	0.25 units on a scale Standard Deviation 0.86	—

PRIMARY outcome

Timeframe: 20 minutes after stimulation start

Population: This measure was only taken for one group of patients.

Outcome measures

Outcome measures
Measure	Acute Stimulation: Vibration Patterns 1-3 and Sham Control n=14 Participants All participants try on several wearable prototypes in our laboratory that provide vibration to the arm. Sensors or electrodes taped onto the arm and hand will sense muscle activity and record any changes during periods of vibration and periods with vibration turned off.	Longitudinal Stimulation: Vibration Pattern 4 1\) If the patient gets Botox injections in their hand and arm, their arm function will be measured for three months during this standard care. 2) Next, all patients will be given a wearable device to take home. The patient will wear the device while feeling vibrations for 3 hours during the day while awake for two months. During this time and 1 month after this intervention, arm function will be tested.
Change in Modified Ashworth During Stimulation (Pattern 3).	1.11 units on a scale Standard Deviation 0.84	—

PRIMARY outcome

Timeframe: 20 minutes after stimulation start

Population: This measure was only taken for one group.