search
Back to results

Passive Tactile Stimulation for Stroke Rehabilitation (PTS)

Primary Purpose

Stroke, Stroke, Ischemic, Stroke Hemorrhagic

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vibration pattern
No vibration
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring spasticity, tone, hemiplegia, hemiparesis, arm, hand, vibration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford Neuroscience Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Vibration pattern 1

Vibration pattern 2

Vibration pattern 3

Vibration pattern 4

Vibration pattern 5

Vibration pattern 6

Vibration pattern 7

Vibration pattern 8

Vibration pattern 9

Vibration pattern 10

No vibration

Arm Description

Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.

Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.

Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.

Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.

Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.

Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.

Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.

Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.

Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.

Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.

A light will blink instead of a vibration pattern being displayed.

Outcomes

Primary Outcome Measures

Change in Modified Ashworth at 12 weeks
Modified Ashworth Scale for Spasticity (upper limb)
Change in Modified Ashworth at 8 weeks
Modified Ashworth Scale for Spasticity (upper limb)
Change in Range of Motion at 12 weeks
Workspace of voluntary movement of arm will be measured
Change in Range of Motion at 8 weeks
Workspace of voluntary movement of arm will be measured

Secondary Outcome Measures

Full Information

First Posted
January 16, 2019
Last Updated
April 26, 2022
Sponsor
Stanford University
search

1. Study Identification

Unique Protocol Identification Number
NCT03814889
Brief Title
Passive Tactile Stimulation for Stroke Rehabilitation
Acronym
PTS
Official Title
Passive Tactile Stimulation for Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 15, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke, Ischemic, Stroke Hemorrhagic, Spasticity as Sequela of Stroke
Keywords
spasticity, tone, hemiplegia, hemiparesis, arm, hand, vibration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vibration pattern 1
Arm Type
Active Comparator
Arm Description
Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
Arm Title
Vibration pattern 2
Arm Type
Active Comparator
Arm Description
Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
Arm Title
Vibration pattern 3
Arm Type
Active Comparator
Arm Description
Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
Arm Title
Vibration pattern 4
Arm Type
Active Comparator
Arm Description
Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
Arm Title
Vibration pattern 5
Arm Type
Active Comparator
Arm Description
Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
Arm Title
Vibration pattern 6
Arm Type
Active Comparator
Arm Description
Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
Arm Title
Vibration pattern 7
Arm Type
Active Comparator
Arm Description
Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
Arm Title
Vibration pattern 8
Arm Type
Active Comparator
Arm Description
Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
Arm Title
Vibration pattern 9
Arm Type
Active Comparator
Arm Description
Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
Arm Title
Vibration pattern 10
Arm Type
Active Comparator
Arm Description
Each tactile vibration pattern will consist of a specific vibration frequency, amplitude, and temporal sequence to be specified via pilot studies.
Arm Title
No vibration
Arm Type
Placebo Comparator
Arm Description
A light will blink instead of a vibration pattern being displayed.
Intervention Type
Device
Intervention Name(s)
Vibration pattern
Intervention Description
PHASE 1 and PHASE 2 are pilot studies not included in the clinical trial. Phase 2b: 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. PHASE 3: Patients will be given a wearable device to take home. The patient will wear the device daily. At the beginning and end of the phase, arm function will be tested. PHASE 4: This study takes 3 or 6 months. 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.
Intervention Type
Device
Intervention Name(s)
No vibration
Intervention Description
These patients will wear a glove with a blinking light instead of feeling vibrations.
Primary Outcome Measure Information:
Title
Change in Modified Ashworth at 12 weeks
Description
Modified Ashworth Scale for Spasticity (upper limb)
Time Frame
Change from Baseline Modified Ashworth at 12 weeks
Title
Change in Modified Ashworth at 8 weeks
Description
Modified Ashworth Scale for Spasticity (upper limb)
Time Frame
Change from Baseline Modified Ashworth at 8 weeks
Title
Change in Range of Motion at 12 weeks
Description
Workspace of voluntary movement of arm will be measured
Time Frame
Change from Baseline Range of Motion at 12 weeks
Title
Change in Range of Motion at 8 weeks
Description
Workspace of voluntary movement of arm will be measured
Time Frame
Change from Baseline Range of Motion at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison M Okamura, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford Neuroscience Health Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Passive Tactile Stimulation for Stroke Rehabilitation

We'll reach out to this number within 24 hrs