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

S

Shepherd Center, Atlanta GA

Status

Completed

Conditions

Tetraplegia
Spinal Cord Injuries

Treatments

Other: Vibrating ball

Study type

Interventional

Funder types

Other

Identifiers

NCT04020770
Shepherd
FV-765 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Vibrating Ball
Experimental group
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.
Treatment:
Other: Vibrating ball

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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