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Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia

Primary Purpose

Spinal Cord Injuries, Tetraplegia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Vibrating ball

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have sustained cervical (neurological level C1-C8) SCI
Any ISNCSCI severity classification (A, B, C or D)
Have therapist-reported and self-reported spasticity in the arm or hand
Ability to pick up, move, and release at least one block (on the Box & Blocks Test)
May participate if utilizing prescription medications, including baclofen pump for control of spasticity

Exclusion Criteria:

Severe contractures of the arm/hand that limit passive movement of the elbow, wrist or fingers more than 50% of normal range of motion or presence of other orthopedic pathology that would adversely influence participation in the protocol
Any implanted catheter such as but not limited to CSF shunt, or the presence of pacemaker, implanted automatic internal cardioverter defibrillator (AICD, other cardiac implants and or conditions). Not including baclofen pump.
Severe pain or hypersensitivity of the arm/hand
Current pregnancy

Sites / Locations

Shepherd Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vibrating Ball

Arm Description

Vibrating ball is held in both hands. Participants complete 5 30-second bouts of 68 Hz vibration with a 1 minute rest in between each bout.

Outcomes

Primary Outcome Measures

Change in Box and Blocks Test from pre-intervention to post intervention, from pre intervention to 20 minute follow up, from post intervention to 20 minute follow up

Functional assessment of grasp and release

Change in Modified Ashworth Scale from pre-intervention to post intervention, from pre intervention to 20 minute follow up, from post intervention to 20 minute follow up

Clinical assessment of stretch-induced spasticity measured on a scale of 0-4 with 4 indicating the worst spasticity and 0 indicating no spasticity detectable upon clinical examination.

Change in Global Impression of Change Scale from pre-intervention to post intervention, from pre intervention to 20 minute follow up, from post intervention to 20 minute follow up

Self-report of improvement or deterioration over time measured on a scale of 1-7 with 1 indicating very much improved and 7 indicating very much worse

Satisfaction and Adherence Questionnaire

Self- report of satisfaction with and perceived ability to adhere to the intervention

Secondary Outcome Measures

Hand strength

Dynamometer measurement of grip strength

Pinch strength

Lateral pinch strength measured using a pinch meter

Semmes-Weinstein Monofilament Test

Assesment of light touch sensation

Qualities of Spasticity Questionnaire

Self-report of experience of spasticity

Full Information

NCT ID

NCT04020770

First Posted

June 4, 2019

Last Updated

July 15, 2019

Sponsor

Shepherd Center, Atlanta GA

Collaborators

Emory University

1. Study Identification

Unique Protocol Identification Number

NCT04020770

Brief Title

Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia

Official Title

Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

October 28, 2018 (Actual)

Primary Completion Date

February 20, 2019 (Actual)

Study Completion Date

February 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shepherd Center, Atlanta GA

Collaborators

Emory University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Vibration therapy is a possible alternative to drug-based treatments for spasticity following SCI. Research indicates that it may provide temporary relief from spasticity, but many interventions under investigation are not portable and therefore access is limited. The aim of this study is to investigate the feasibility of using a portable vibrating device to decrease UE spasticity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries, Tetraplegia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vibrating Ball

Arm Type

Experimental

Arm Description

Vibrating ball is held in both hands. Participants complete 5 30-second bouts of 68 Hz vibration with a 1 minute rest in between each bout.

Intervention Type

Other

Intervention Name(s)

Vibrating ball

Intervention Description

Parameters: 5 30-sec bouts of 68Hz vibration followed by a 1-minute rest.

Primary Outcome Measure Information:

Title

Change in Box and Blocks Test from pre-intervention to post intervention, from pre intervention to 20 minute follow up, from post intervention to 20 minute follow up

Description

Functional assessment of grasp and release

Time Frame

Day 1

Title

Change in Modified Ashworth Scale from pre-intervention to post intervention, from pre intervention to 20 minute follow up, from post intervention to 20 minute follow up

Description

Clinical assessment of stretch-induced spasticity measured on a scale of 0-4 with 4 indicating the worst spasticity and 0 indicating no spasticity detectable upon clinical examination.

Time Frame

Day 1

Title

Change in Global Impression of Change Scale from pre-intervention to post intervention, from pre intervention to 20 minute follow up, from post intervention to 20 minute follow up

Description

Self-report of improvement or deterioration over time measured on a scale of 1-7 with 1 indicating very much improved and 7 indicating very much worse

Time Frame

Day 1

Title

Satisfaction and Adherence Questionnaire

Description

Self- report of satisfaction with and perceived ability to adhere to the intervention

Time Frame

20 minute delay post intervention

Secondary Outcome Measure Information:

Title

Hand strength

Description

Dynamometer measurement of grip strength

Time Frame

Pre-intervention, immediately post-intervention, 20 minute delay post intervention

Title

Pinch strength

Description

Lateral pinch strength measured using a pinch meter

Time Frame

Pre-intervention, immediately post-intervention, 20 minute delay post intervention

Title

Semmes-Weinstein Monofilament Test

Description

Assesment of light touch sensation

Time Frame

Pre-intervention, immediately post-intervention, 20 minute delay post intervention

Title

Qualities of Spasticity Questionnaire

Description

Self-report of experience of spasticity

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have sustained cervical (neurological level C1-C8) SCI Any ISNCSCI severity classification (A, B, C or D) Have therapist-reported and self-reported spasticity in the arm or hand Ability to pick up, move, and release at least one block (on the Box & Blocks Test) May participate if utilizing prescription medications, including baclofen pump for control of spasticity Exclusion Criteria: Severe contractures of the arm/hand that limit passive movement of the elbow, wrist or fingers more than 50% of normal range of motion or presence of other orthopedic pathology that would adversely influence participation in the protocol Any implanted catheter such as but not limited to CSF shunt, or the presence of pacemaker, implanted automatic internal cardioverter defibrillator (AICD, other cardiac implants and or conditions). Not including baclofen pump. Severe pain or hypersensitivity of the arm/hand Current pregnancy

Facility Information:

Facility Name

Shepherd Center

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30309

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Influence of Upper Extremity Vibration on Spasticity and Function in Persons With Tetraplegia

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