Prevention of Post-Stroke Hand/Wrist Flexion Deformity

NCT00628537 | Completed Phase 1

• 1 other identifier: BT4
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The study looks at a new treatment for wrist and finger contractures -- a condition where the affected hand is in a "closed" position, with the wrist and fingers stiff and difficult to move from that position. We want to study if stimulation of wrist and finger muscles using an implanted neuromuscular stimulator (BION) will be more or less effective than doing passive exercises of the affected hand to improve the range of movement at wrist and finger joints. Subjects of this study will be randomized into one of three groups: one doing passive movement therapy; one receiving surface stimulation (electrical stimulation with electrodes on the skin of the arm) and one doing BION® therapy. The passive movement group will do therapy for 12 weeks. Subjects in either stimulation group will receive stimulation for 6 weeks and then only passive therapy for 6 weeks.

Conditions

Hand Deformities

Keywords

Neuromuscular stimulator; Flexor deformities of wrist and fingers

Outcome Measures

Primary Outcomes (1)

• passive Range of Motion, active Range of Motion, Rancho Arm Function Scale, Fugl Meyer Function Scale

  baseline, 2 weeks, 4 weeks and 6 weeks

Study Arms (3)

1

EXPERIMENTAL

BION™ Experimental Group

Device: BION stimulation

2

ACTIVE COMPARATOR

Surface Stimulation Group

Device: BION stimulation

3

ACTIVE COMPARATOR

Control Group with conservative therapy (Range of motion exercises)

Device: BION stimulation

Interventions

BION stimulation DEVICE

BION™ Experimental Group The goal for the BION™ patients is to achieve 30 minutes of stimulation twice daily, using a cycled stimulation at frequencies adequate to produce tetanic contraction, (typically 25-35 pps) that raises the joint through full range of motion against gravity (a range graded as 3/5) based on the available range of motion. Surface Stimulation Group Patients will be instructed to stimulate twice daily for 30 minutes through surface electrodes placed according to instructions that the subject has been given. Every effort will be made to ensure that the parameters needed in this group are chosen to produce a similar type of contraction to that obtained with BION™ stimulation. Control Group with conservative therapy (Range of motion exercises) The research participant is instructed in self-administered, standard range of motion stretching exercises.

1; 2; 3

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of hemiplegic stroke 6 months to 20 years prior to enrollment in this study;
• Paresis of extensors in the forearm;
• Demonstrable restriction of hand or wrist mobility (i.e. significant stretch response, defined as a 2+ or greater on the Ashworth scale, can be elicited in the finger or wrist flexor muscles, and the patient's resting hand posture is flexed when the patient is standing with the upper arm pendant and the elbow flexed);
• Age 18 years or older;
• Stable pattern of pain-medication use for at least one month prior to enrollment;
• Medically stable;
• Able to travel to the testing center;
• Mentally capable to understand and carry out the procedures and communicate concerns; and
• Able and willing to participate and provide informed consent.
• Ability to bring the wrist into neutral posture and the MCP joints into 30 degrees of flexion

You may not qualify if:

• Pregnant, nursing, or planning to become pregnant within the study timeframe;
• Presence of electronic implants (e.g., cardiac pacemaker, cochlear implant, neurostimulator, etc.);
• Presence of metallic implants, such as artificial elbow implants or metal screws, in the immediate field of the magnetic coil (on the arm between the fingers and the shoulder).
• Use of electrical stimulation for treatment of relevant extensor muscles in the past month;
• Inability to recruit muscles through surface electrical stimulation because of excessive adipose tissue;
• Presence of other unrelated hand or wrist pathologies; participating in other treatments including active physical therapy or drug therapy that affect their hand or wrist.
• Severe hemineglect; and
• Cancer or other serious illness, including a disease other than stroke resulting in motor dysfunction.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Rancho Los Angeles National Rehabilitation Center

Downey, California, 90242, United States

Location

Related Publications (1)

• Loeb GE, Richmond FJ, Baker LL. The BION devices: injectable interfaces with peripheral nerves and muscles. Neurosurg Focus. 2006 May 15;20(5):E2. doi: 10.3171/foc.2006.20.5.3.

  PMID: 16711659 RESULT

MeSH Terms

Conditions

Hand Deformities

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases

Study Officials

• Lucinda Baker, M.D.

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2008
• First Posted: March 5, 2008
• Study Start: April 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

US (1)