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

NCT ID: NCT04020770

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-28
• Study Completion Date: 2019-02-20

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.

Conditions

Spinal Cord Injuries; Tetraplegia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vibrating Ball

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.

Group Type: EXPERIMENTAL

Vibrating ball

Intervention Type: OTHER

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

Interventions

Vibrating ball

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

Shepherd Center, Atlanta GA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shepherd Center

Atlanta, Georgia, United States

Countries

United States

Other Identifiers

FV-765

Identifier Type: OTHER

Identifier Source: secondary_id

Shepherd

Identifier Type: -

Identifier Source: org_study_id