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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04020770
• Other study ID #: Shepherd
• Secondary ID: FV-765
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Quadriplegia
• Spinal Cord Injuries
• Tetraplegia

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