Improving Hand and Arm Function After Spinal Cord Injury (SCI)

October 9, 2013 updated by: Edelle Field-Fote, University of Miami

Improving Hand and Arm Function After SCI

The long-term goal of this project is to develop rehabilitation strategies that facilitate optimal restoration of skilled hand use in individuals with spinal cord injury (SCI). The objective of the studies proposed in this application is to determine whether a protocol of massed practice + somatosensory stimulation (MP+SS) is more effective for improving skilled hand use compared to a somatosensory stimulation (SS) alone, and to determine whether these approaches are each more effective than traditional therapy (consisting of conventional resistance training; CRT).

Specific Aim I: In individuals with chronic incomplete tetraplegia, quantify changes in skilled hand use and sensory function associated with either: massed practice training combined with somatosensory stimulation (MP+SS), somatosensory stimulation (SS), or control (conventional resistance training [CRT]), and compare differences among groups. The investigators hypothesize that:

H1.1: At the end of 4 weeks, gains in scores on standardized tests of skilled hand motor function (Jebsen-Taylor Hand Function Test and Chedoke-McMaster Arm and Hand Activity Inventory) and sensory function (quantitative sensory tests; QST) will be greater in individuals who are trained using MP+SS compared to the SS and RT groups.

H1.2: At the end of 4 weeks, gains in scores on standardized tests of skilled hand motor function and sensory function tests will be greater in individuals who are trained using SS compared to CRT.

H1.3: At 6 months post training, motor and sensory gains will be retained by the MP+SS and SS groups.

Specific Aim 2: In individuals with chronic incomplete tetraplegia, quantify changes in cortical and spinal neurophysiology associated with either: massed practice combined with somatosensory stimulation (MP+SS), somatosensory stimulation (SS), or control (conventional resistance training [CRT]), and compare differences among groups. The investigators hypothesize that, after 4 weeks:

H2.1: Measures representing cortical neurophysiologic function (i.e., motor-evoked potential amplitude and location of cortical map) will show greater change in the direction of more normal values in individuals who are trained using MP+SS compared to the SS and the CRT groups.

H2.2: Measures representing spinal neurophysiologic function (i.e., F-wave and H-reflex amplitude) will show greater change in the direction of more normal values in individuals who are trained using SS compared to the MP+SS and the CRT groups.

H2.3: There will be a positive relationship between change scores associated with functional outcome measures and cortical neurophysiologic outcome measures in the MP+SS group; there will be a positive relationship between change scores associated with the functional outcome measures and spinal neurophysiologic outcome measures in the SS group.

Specific Aim 3: In individuals with chronic incomplete tetraplegia, quantify changes in self-assessment of quality of life and societal participation associated with massed practice combined with somatosensory stimulation (MP+SS), somatosensory stimulation (SS) or control (conventional resistance training [CRT]), and compare difference among groups. The investigators hypothesize that:

H3.1: Gains in scores on standardized measures of quality of life (Medical Outcomes Study Short Form 36 [SF-36]) and societal participation (Impact on Participation and Autonomy Questionnaire [IPAQ]) will be greater in individuals who are trained using MP+SS compared to both the SS and the CRT groups.

H3.2: Gains in scores on standardized measures of quality of life and societal participation will be greater in individuals who are trained using SS compared to the CRT group.

H3.3: At 6 months post training, gains in the quality of life and the societal participation measures will be retained by the MP+SS and SS groups.

Risks: This is a low risk study that investigates the effects of standard rehabilitation and exercise interventions on hand/arm function in individuals with SCI. All devices are considered minimal risk devices by the FDA.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Evidence suggests that both intensive, skill-based practice training combined with somatosensory stimulation (MP+SS) and somatosensory stimulation alone (SS) may be associated with functional changes that are greater than those associated with skill-based training alone (MP). These studies are significant in that they advance the field of rehabilitation science as it relates to the goal of improving skilled hand use in individuals with SCI; there are few goals that have more important implications for function, independence and quality of life in these individuals.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33131
        • The Miami Project to Cure Paralysis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • traumatic spinal cord injury of at least one-year duration
  • injury to cervical spinal cord at C7 or higher
  • sufficient strength of thenar muscles to generate, at minimum, a visible twitch contraction in at least one thumb

Exclusion Criteria:

  • history of head trauma and/or cognitive deficit
  • subject history of stroke, seizures or other intracranial disease
  • family history of seizures
  • inability to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Somatosensory stimulation (SS)
Participants in the SS group receive median nerve electrical stimulation applied to the skin of the wrists.
Other: Arm and hand training
Individuals will receive either: somatosensory stimulation isolated or combined with a skill-based exercise protocol, or a conventional strengthening program.
Active Comparator: Massed practice + somatosensory stimulation (MP+SS)
Participants in the MP+SS group receive a combined intervention consisting of SS and a skill-based exercise protocol
Other: Arm and hand training
Individuals will receive either: somatosensory stimulation isolated or combined with a skill-based exercise protocol, or a conventional strengthening program.
Active Comparator: Conventional resistance training (CRT)
Participants in the CRT group will participate in a weight-based exercise program
Other: Arm and hand training
Individuals will receive either: somatosensory stimulation isolated or combined with a skill-based exercise protocol, or a conventional strengthening program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Jebsen-Taylor Hand Function Test
Time Frame: 4 weeks
The Jebsen Test is an assessment of hand function and improvement in hand function associated with therapeutic procedures. Individuals with cervical SCI are included in the target population for use of the test. The test is comprised of 7 subtests, including writing, turning over cards, picking up small common objects, simulated feeding, stacking checkers, picking up large light objects, and picking up large heavy objects.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cortical motor excitability via transcranial magnetic stimulation (TMS)
Time Frame: 4 weeks
The motor threshold (intensity required to evoke 5/10 motor evoked potentials), a recruitment curve (from 80% of the motor threshold to the maximum stimulator output, in increments of 20%), and the thenar motor map (number of active sites for the thenar muscles in the hand motor cortical distribution) will be recorded via TMS.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

June 11, 2010

First Submitted That Met QC Criteria

June 11, 2010

First Posted (Estimate)

June 14, 2010

Study Record Updates

Last Update Posted (Estimate)

October 10, 2013

Last Update Submitted That Met QC Criteria

October 9, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HD053854 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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