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Trial Outcomes & Findings for New Tool to Enhance Post-stroke Upper Extremity Disability (NCT NCT05277389)

NCT ID: NCT05277389

Last Updated: 2025-06-25

Results Overview

The Action Research Arm Test (ARAT) assesses upper extremity function, specifically arm and hand motor abilities, in individuals with neurological conditions. The test evaluates grasp, grip, pinch, and gross movement through 19 standardized tasks. Each task is scored from 0 (no movement) to 3 (normal movement), yielding four subscale scores (Grasp, Grip, Pinch, Gross Movement) that are summed to compute a total score. The total score ranges from 0 to 57, with higher scores indicating better upper extremity function. Subscale ranges are: Grasp (0-18), Grip (0-12), Pinch (0-18), and Gross Movement (0-9). The outcome measure reports the change in the total ARAT score from baseline to post-intervention, with positive values reflecting improved function. Scores are reported as units on a scale.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

21 participants

Primary outcome timeframe

Time from Baseline to Post-intervention (1 week intervention, 1 month post intervention - total 5 weeks time frame)

Results posted on

2025-06-25

Participant Flow

Recruitment period: 12/20/22 - 12/15/23 Locations: Medical clinics, community fliers, gyms, events related to stroke, online community groups and members.

3 participants withdrawn for reasons as follow: 1 safety concern pertaining to mobility, 1 upper extremity pain, 1 illness before 1st session

Participant milestones

Participant milestones
Measure
Control
Individuals in this group will practice object manipulation tasks without the START (Startle Adjuvant Rehabilitation Therapy) intervention Sham Control: Practice of Movement task without START
START
Individuals in this group with practice object manipulation tasks with the START condition (startling acoustic stimuli applied during 33% of trials) START - Startle Adjuvant Rehabilitation Therapy: Application of startling acoustic stimuli during practice of movement task
Overall Study
STARTED
11
10
Overall Study
COMPLETED
10
6
Overall Study
NOT COMPLETED
1
4

Reasons for withdrawal

Reasons for withdrawal
Measure
Control
Individuals in this group will practice object manipulation tasks without the START (Startle Adjuvant Rehabilitation Therapy) intervention Sham Control: Practice of Movement task without START
START
Individuals in this group with practice object manipulation tasks with the START condition (startling acoustic stimuli applied during 33% of trials) START - Startle Adjuvant Rehabilitation Therapy: Application of startling acoustic stimuli during practice of movement task
Overall Study
Lost to Follow-up
1
4

Baseline Characteristics

New Tool to Enhance Post-stroke Upper Extremity Disability

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control
n=11 Participants
Individuals in this group will practice object manipulation tasks without the START (Startle Adjuvant Rehabilitation Therapy) intervention Sham Control: Practice of Movement task without START
START
n=10 Participants
Individuals in this group with practice object manipulation tasks with the START condition (startling acoustic stimuli applied during 33% of trials) START - Startle Adjuvant Rehabilitation Therapy: Application of startling acoustic stimuli during practice of movement task
Total
n=21 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
6 Participants
n=5 Participants
8 Participants
n=7 Participants
14 Participants
n=5 Participants
Age, Categorical
>=65 years
5 Participants
n=5 Participants
2 Participants
n=7 Participants
7 Participants
n=5 Participants
Age, Continuous
59 years
STANDARD_DEVIATION 13 • n=5 Participants
48 years
STANDARD_DEVIATION 19 • n=7 Participants
54 years
STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
5 Participants
n=7 Participants
9 Participants
n=5 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
5 Participants
n=7 Participants
12 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
4 Participants
n=7 Participants
5 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants
n=5 Participants
6 Participants
n=7 Participants
16 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
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
White
10 Participants
n=5 Participants
8 Participants
n=7 Participants
18 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 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
11 participants
n=5 Participants
10 participants
n=7 Participants
21 participants
n=5 Participants

PRIMARY outcome

Timeframe: Time from Baseline to Post-intervention (1 week intervention, 1 month post intervention - total 5 weeks time frame)

The Action Research Arm Test (ARAT) assesses upper extremity function, specifically arm and hand motor abilities, in individuals with neurological conditions. The test evaluates grasp, grip, pinch, and gross movement through 19 standardized tasks. Each task is scored from 0 (no movement) to 3 (normal movement), yielding four subscale scores (Grasp, Grip, Pinch, Gross Movement) that are summed to compute a total score. The total score ranges from 0 to 57, with higher scores indicating better upper extremity function. Subscale ranges are: Grasp (0-18), Grip (0-12), Pinch (0-18), and Gross Movement (0-9). The outcome measure reports the change in the total ARAT score from baseline to post-intervention, with positive values reflecting improved function. Scores are reported as units on a scale.

Outcome measures

Outcome measures
Measure
Control
n=11 Participants
Individuals in this group will practice object manipulation tasks without the START (Startle Adjuvant Rehabilitation Therapy) intervention Sham Control: Practice of Movement task without START
START
n=10 Participants
Individuals in this group with practice object manipulation tasks with the START condition (startling acoustic stimuli applied during 33% of trials) START - Startle Adjuvant Rehabilitation Therapy: Application of startling acoustic stimuli during practice of movement task
Change in Action Research Arm Test (ARAT) Total Score From Baseline to Post-Intervention
0.72 Units on a scale
Standard Deviation 1.737292
0 Units on a scale
Standard Deviation 2.692582

PRIMARY outcome

Timeframe: Comparing baseline to one-month post (1 month post intervention - total 5 weeks time frame)

The Action Research Arm Test (ARAT) assesses upper extremity function, specifically arm and hand motor abilities, in individuals with neurological conditions. The test evaluates grasp, grip, pinch, and gross movement through 19 standardized tasks. Each task is scored from 0 (no movement) to 3 (normal movement), yielding four subscale scores (Grasp, Grip, Pinch, Gross Movement) that are summed to compute a total score. The total score ranges from 0 to 57, with higher scores indicating better upper extremity function. Subscale ranges are: Grasp (0-18), Grip (0-12), Pinch (0-18), and Gross Movement (0-9). The outcome measure reports the change in the total ARAT score from baseline to post-intervention, with positive values reflecting improved function. Scores are reported as units on a scale.

Outcome measures

Outcome measures
Measure
Control
n=11 Participants
Individuals in this group will practice object manipulation tasks without the START (Startle Adjuvant Rehabilitation Therapy) intervention Sham Control: Practice of Movement task without START
START
n=10 Participants
Individuals in this group with practice object manipulation tasks with the START condition (startling acoustic stimuli applied during 33% of trials) START - Startle Adjuvant Rehabilitation Therapy: Application of startling acoustic stimuli during practice of movement task
Retention in Action Research Arm Test (ARAT)
1 Units on a scale
Standard Deviation 1.603567
-0.666667 Units on a scale
Standard Deviation 3.204164

PRIMARY outcome

Timeframe: Time from Baseline to Post-intervention (1 week intervention, 1 month post intervention - total 5 weeks time frame)

The Motor Activity Log (MAL) assesses arm use in daily activities post-stroke. The Amount of Use subscale (0-5) rates 30 tasks; higher scores mean more use. Total score averages task scores (0-5). Change in total score is reported. Units on a scale. MAL was taken at baseline and then at one-month post intervention.

Outcome measures

Outcome measures
Measure
Control
n=11 Participants
Individuals in this group will practice object manipulation tasks without the START (Startle Adjuvant Rehabilitation Therapy) intervention Sham Control: Practice of Movement task without START
START
n=10 Participants
Individuals in this group with practice object manipulation tasks with the START condition (startling acoustic stimuli applied during 33% of trials) START - Startle Adjuvant Rehabilitation Therapy: Application of startling acoustic stimuli during practice of movement task
Change in Motor Activity Log (MAL) Amount of Use Score From Baseline to Post-Intervention
-2.045455 units on scale
Standard Deviation 12.02384
0.388889 units on scale
Standard Deviation 5.085382

PRIMARY outcome

Timeframe: Retention of measure comparing baseline to one-month

The Motor Activity Log (MAL) assesses arm use in daily activities post-stroke. The Amount of Use (AOU) subscale (0-5) rates 30 tasks; higher scores indicate more use. The total score sums the 30 AOU task scores, ranging from 0 to 150. Units on a scale.

Outcome measures

Outcome measures
Measure
Control
n=11 Participants
Individuals in this group will practice object manipulation tasks without the START (Startle Adjuvant Rehabilitation Therapy) intervention Sham Control: Practice of Movement task without START
START
n=10 Participants
Individuals in this group with practice object manipulation tasks with the START condition (startling acoustic stimuli applied during 33% of trials) START - Startle Adjuvant Rehabilitation Therapy: Application of startling acoustic stimuli during practice of movement task
Retention in Motor Activity Log (MAL)
5.0625 units on scale
Standard Deviation 8.174164
12.75 units on scale
Standard Deviation 21.731889

SECONDARY outcome

Timeframe: Time from Baseline to Post-intervention (1 week intervention, 1 month post intervention - total 5 weeks time frame)

The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) evaluates motor function post-stroke via 33 tasks. Total score (0-66) sums subscales: shoulder/arm (0-36), wrist/hand (0-24), coordination (0-6). Higher scores indicate better function. Units on a scale. FMA-UE was taken at baseline and then at one-month post intervention.

Outcome measures

Outcome measures
Measure
Control
n=11 Participants
Individuals in this group will practice object manipulation tasks without the START (Startle Adjuvant Rehabilitation Therapy) intervention Sham Control: Practice of Movement task without START
START
n=10 Participants
Individuals in this group with practice object manipulation tasks with the START condition (startling acoustic stimuli applied during 33% of trials) START - Startle Adjuvant Rehabilitation Therapy: Application of startling acoustic stimuli during practice of movement task
Change in Upper Extremity Fugl Meyer (UEFM) Baseline to Post-intervention
0.090909 units on a scale
Standard Deviation 3.935849
1.555556 units on a scale
Standard Deviation 3.574602

SECONDARY outcome

Timeframe: Retention of measure comparing baseline to one-month post training

The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) evaluates motor function post-stroke via 33 tasks. Total score (0-66) sums subscales: shoulder/arm (0-36), wrist/hand (0-24), coordination (0-6). Higher scores indicate better function. Units on a scale.

Outcome measures

Outcome measures
Measure
Control
n=11 Participants
Individuals in this group will practice object manipulation tasks without the START (Startle Adjuvant Rehabilitation Therapy) intervention Sham Control: Practice of Movement task without START
START
n=10 Participants
Individuals in this group with practice object manipulation tasks with the START condition (startling acoustic stimuli applied during 33% of trials) START - Startle Adjuvant Rehabilitation Therapy: Application of startling acoustic stimuli during practice of movement task
Retention of Upper Extremity Fugl Meyer From End Training to One-month Post
-0.5 units on a scale
Standard Deviation 5.291503
-0.333333 units on a scale
Standard Deviation 5.715476

SECONDARY outcome

Timeframe: Change from baseline to post-intervention (1 week intervention, 1 month post intervention - total 5 weeks time frame)

The Stroke Impact Scale (SIS) measures quality of life and functional recovery post-stroke across 8 subscales: strength (0-100), hand function (0-100), mobility (0-100), ADL (0-100), emotion (0-100), memory (0-100), communication (0-100), participation (0-100). Each subscale score is scaled to 0-100; higher scores indicate better outcomes. The total score (0-100) averages the subscale scores. Change in total score is reported. Units on a scale.

Outcome measures

Outcome measures
Measure
Control
n=11 Participants
Individuals in this group will practice object manipulation tasks without the START (Startle Adjuvant Rehabilitation Therapy) intervention Sham Control: Practice of Movement task without START
START
n=10 Participants
Individuals in this group with practice object manipulation tasks with the START condition (startling acoustic stimuli applied during 33% of trials) START - Startle Adjuvant Rehabilitation Therapy: Application of startling acoustic stimuli during practice of movement task
Change in Stroke Impact Scale From Baseline to Post-intervention
0.363636 units on a scale
Standard Deviation 2.01359
-0.777778 units on a scale
Standard Deviation 1.922094

SECONDARY outcome

Timeframe: Change from baseline to one-month post training

The Stroke Impact Scale (SIS) measures quality of life and functional recovery post-stroke across 8 subscales: strength (0-100), hand function (0-100), mobility (0-100), ADL (0-100), emotion (0-100), memory (0-100), communication (0-100), participation (0-100). Each subscale score is scaled to 0-100; higher scores indicate better outcomes. The total score (0-100) averages the subscale scores. Change in total score is reported. Units on a scale.

Outcome measures

Outcome measures
Measure
Control
n=11 Participants
Individuals in this group will practice object manipulation tasks without the START (Startle Adjuvant Rehabilitation Therapy) intervention Sham Control: Practice of Movement task without START
START
n=10 Participants
Individuals in this group with practice object manipulation tasks with the START condition (startling acoustic stimuli applied during 33% of trials) START - Startle Adjuvant Rehabilitation Therapy: Application of startling acoustic stimuli during practice of movement task
Retention of Stroke Impact Scale - Post-training to One-month Post
-1.375 units on a scale
Standard Deviation 1.685018
2.5 units on a scale
Standard Deviation 3.391165

Adverse Events

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Start - Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Claire Honeycutt, Associate Professor

Arizona State University

Phone: 4809658453

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place