Effectiveness of START (Startle Adjuvant Rehabilitation Therapy) in Enhancing Arm Function Post-Stroke

NCT05881096 | Unknown Early Phase 1

• 1 other identifier: STUDY00002440b
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test the effectiveness of START (Startle Adjuvant Rehabilitation Therapy) in improving arm function after a stroke. The main questions it aims to answer are 1) Does startle rehabilitation therapy improve functional arm performance after training on a specific task and 2) Can training benefits, if any, be seen in other untrained tasks? Researchers will enroll participants across a wide range of upper extremity impairments post-stroke. Participants will be enrolled in three consecutive days of in-person training on an upper extremity task followed by a single-day follow-up session one month after training is completed. Each training session will last for approximately 3 hours per day. Participants will be randomly assigned to one of two groups; 1) Arm training with START and 2) Arm training without START. Study participants and assessors will be blinded to the type of training received. Before the training, participants will be clinically assessed to determine impairment level. During training, participants will be asked to perform; 1) a simulated feed task which involves transferring kidney beans using a spoon from one cup (start position) to another cup (end position) in front of them OR 2) A functional reaching task where participants will maintain a tool (spoon) in their hand while extending their arm forward towards an end position based on the severity of arm impairment as determined by the clinical assessment. Researchers will compare the % change in trained task scores, muscle activity, and arm movement outcome measures at three-time points; baseline on day 1, at the end of training on day 3, and one month after training.

Conditions

Stroke

Keywords

Hemiplegia; Upper extremity impairment

Outcome Measures

Primary Outcomes (8)

• Change in EMG (electromyography) onset (in ms) during functional reaching task

  Evaluation of EMG onset measured in milliseconds (ms) for different muscles of the affected / most affected arm. EMG activity will be recorded using Ag/Cl surface electrodes and onset will be detected using a custom MATLAB code.

  Change in EMG onset from baseline (before training on day 1) to post (after training on day 3)

• Change in EMG (electromyography) amplitude (in mV) during the functional reaching task

  Evaluation of EMG amplitude measured in millivolts(mV) for different muscles of the affected / most affected arm. EMG activity will be recorded using Ag/Cl surface electrodes and amplitude will be detected using a custom MATLAB code.

  Change in EMG amplitude from baseline (before training on day 1) to post (after training on day 3)

• Change in movement onset (in ms) on functional reaching task

  Evaluation of movement onset in milliseconds(ms). Movement activity will be measured using Infrared(IR) markers placed at fixed joint locations on the arm. Movement onset will be detected using a custom MATLAB code.

  Change in movement onset from baseline (before training on day 1) to post (after training on day 3)

• Change in movement linearity (in mm) on functional reaching task

  Evaluation of movement linearity in millimeters (mm). Movement activity using Infrared(IR) markers placed at fixed joint locations on the arm. Movement linearity will be evaluated using a custom MATLAB code.

  Change in movement linearity from baseline (before training on day 1) to post (after training on day 3)

• Change in functional reaching task scores during training

  The functional reaching task (simulated feeding task) is scored based on the number of successful repetitions i.e. the total number of kidney beans successfully transferred or dropped.

  Change in functional reaching task scores from on day 1 of training compared to day 3 of training

• Change in functional reaching task scores

  The functional reaching task (simulated feeding task) is scored based on the number of successful repetitions i.e. the total number of kidney beans successfully transferred or dropped.

  Change in functional reaching task scores from baseline (before training on day 1) to post (after training on day 3)

• Change in sorting task scores

  The change in sorting task scores will be used to evaluate skill transfer. The sorting evaluates an untrained task with spatiotemporally similar characteristics to the trained task. A higher score indicates a better performance.

  Change in sorting task scores from baseline (before training on day 1) to post (after training on day 3)

• Change in dressing task scores

  The change in dressing task scores will be used to evaluate skill transfer. The dressing task evaluates an untrained task with spatiotemporally dissimilar characteristics to the trained task. A higher score indicates a better performance.

  Change in dressing task scores from baseline (before training on day 1) to post (after training on day 3)

Secondary Outcomes (3)

• Retention in functional reaching task scores

  Retention of functional reaching task comparing immediately after training on day 3 to one-month post

• Retention in skill transfer 1 : sorting task scores

  Retention of sorting task comparing immediately after training on day 3 to one-month post

• Retention in skill transfer 2: dressing task

  Retention of sorting task comparing immediately after training on day 3 to one-month post

Study Arms (2)

START (Startle Adjuvant Rehabilitation Therapy)

EXPERIMENTAL

Participants in this group practice a functional reaching task with the START condition (startling acoustic stimuli applied during 33% of trials).

Other: START - Startle Adjuvant Rehabilitation Therapy

Control

SHAM COMPARATOR

Participants in this group will practice a functional reaching task without the START (Startle Adjuvant Rehabilitation Therapy) intervention

Other: Sham Control

Interventions

START - Startle Adjuvant Rehabilitation Therapy OTHER

Application of startling acoustic stimuli during practice of movement task

START (Startle Adjuvant Rehabilitation Therapy)

Sham Control OTHER

Practice of movement task without START

Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years old
• Capacity to provide informed consent
• Cerebral stroke at least 6 months prior to testing
• Presence of severe-to-mild upper extremity impairment
• Corrected pure tone threshold (octave frequencies 250- 4000 Hz) norms for their age and gender. NOTE: Audiometry data will be collected for all participants by lab personnel trained by an audiologist in a sound-attenuated booth. The investigators expect that \~30% of participants will use hearing aids; the investigators will not exclude these individuals but rather include hearing aid use as a covariate in analyses.

You may not qualify if:

• Severe concurrent medical problems (e.g. uncontrolled cardiorespiratory impairment)
• Acute/painful condition/injury of upper extremity/spine that interfere with ability to participate.

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Arizona State University

Tempe, Arizona, 85287, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Claire F Honeycutt, Ph.D

CONTACT

480- 965-8453; cfhoneyc@asu.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: May 31, 2023
• Study Start: June 7, 2022
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

US (1)