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

NCT04020770 | Completed

• 2 other identifiers: ShepherdFV-765
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• Satisfaction and Adherence Questionnaire

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

  20 minute delay post intervention

Secondary Outcomes (4)

• Hand strength

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

• Pinch strength

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

• Semmes-Weinstein Monofilament Test

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

• Qualities of Spasticity Questionnaire

  Baseline

Study Arms (1)

Vibrating Ball

EXPERIMENTAL

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.

Other: Vibrating ball

Interventions

Vibrating ball OTHER

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

Vibrating Ball

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shepherd Center, Atlanta GA: lead
• Emory University: collaborator

Study Sites (1)

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: July 16, 2019
• Study Start: October 28, 2018
• Primary Completion: February 20, 2019
• Study Completion: February 20, 2019
• Last Updated: July 16, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)