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Completed

NCT Number: NCT03814889

Passive Tactile Stimulation for Stroke Rehabilitation

Stroke can lead to weakness and spasticity in the arm or hand. The purpose of this study is to optimize the design of gentle vibratory stimulation delivered to the hands of individuals with chronic stroke, and explore the effect on range of movement and spasticity.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Hemorrhagic Stroke Ischemic Stroke Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Paralysis Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasticity as Sequela of Stroke Stroke Hemorrhagic Stroke, Ischemic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Neuroscience Health Center

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 and older.
  • diagnosis of stroke with upper extremity spasticity or other movement deficits that affect strength and range of movement.
  • willing to participate in the vibrotactile stimulation sessions for consecutive days and willing to return for follow up visits as needed for the PHASE in progress.
  • able to provide informed consent.

Exclusion criteria

  • Patients with severe contracture that precludes Modified Ashworth Score (MAS) testing.

Treatment and study plan

Vibration pattern

Device

Vibration patterns applied to the affected limb based on pilot study results.

No vibration

Device

These patients will wear a glove with a blinking light instead of feeling vibrations.

Primary outcomes

  1. Change in Modified Ashworth at 12 Weeks

    Time frame: Change from Baseline Modified Ashworth at 12 weeks

    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

  2. Change in Modified Ashworth at 8 Weeks

    Time frame: Change from Baseline Modified Ashworth at 8 weeks

    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

  3. Change in Range of Motion at 8 Weeks

    Time frame: Change from Baseline Range of Motion at 8 weeks

    Finger extension range.

  4. Change in Range of Motion at 12 Weeks

    Time frame: Change from Baseline Range of Motion at 12 weeks

    Finger extension range.

  5. Change in Modified Ashworth During Stimulation (Pattern 1).

    Time frame: 20 minutes after stimulation start

    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

  6. Change in Modified Ashworth During Stimulation (Pattern 2).

    Time frame: 20 minutes after stimulation start

    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

  7. Change in Modified Ashworth During Stimulation (Pattern 3).

    Time frame: 20 minutes after stimulation start

    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

  8. Change in Modified Ashworth During Stimulation (Sham Control).

    Time frame: 20 minutes after stimulation start

    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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Acronym: PTS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 24, 2019
Registry last updated
Apr 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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