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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04020770
Other study ID # Shepherd
Secondary ID FV-765
Status Completed
Phase N/A
First received
Last updated
Start date October 28, 2018
Est. completion date February 20, 2019

Study information

Verified date July 2019
Source Shepherd Center, Atlanta GA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date February 20, 2019
Est. primary completion date February 20, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Shepherd Center Atlanta Georgia

Sponsors (2)

Lead Sponsor Collaborator
Shepherd Center, Atlanta GA Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Day 1
Primary 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. Day 1
Primary 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 Day 1
Primary Satisfaction and Adherence Questionnaire Self- report of satisfaction with and perceived ability to adhere to the intervention 20 minute delay post intervention
Secondary Hand strength Dynamometer measurement of grip strength Pre-intervention, immediately post-intervention, 20 minute delay post intervention
Secondary Pinch strength Lateral pinch strength measured using a pinch meter Pre-intervention, immediately post-intervention, 20 minute delay post intervention
Secondary Semmes-Weinstein Monofilament Test Assesment of light touch sensation Pre-intervention, immediately post-intervention, 20 minute delay post intervention
Secondary Qualities of Spasticity Questionnaire Self-report of experience of spasticity Baseline
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