Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury

NCT01005615 | Terminated Phase 1 Results DMC FDA Device

• 3 other identifiers: NA_00014481w81xwh-08-2-0192W81XWH-09-2-0186
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

To determine whether functional electrical stimulation (FES) promotes neurological and physical recovery in patients with spinal cord injury (SCI). The researchers will investigate the extent of functional recovery in patients with spinal cord injury who receive functional electrical stimulation in the upper extremities compared with patients who do not receive FES.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (8)

• Severity of Gleno-humeral Subluxation

  This is a routine exam performed to assess shoulder subluxation. The space between the glenoid and head of the humerus can be visualized on plain X-rays and measured, in centimeters, to grade severity. This test is done bilaterally

  Baseline

• Severity of Gleno-humeral Subluxation

  This is a routine exam performed to assess shoulder subluxation. The space between the glenoid and head of the humerus can be visualized on plain X-rays and measured, in centimeters, to grade severity. This test is done bilaterally

  4 months

• Severity of Gleno-humeral Subluxation

  This is a routine exam performed to assess shoulder subluxation. The space between the glenoid and head of the humerus can be visualized on plain X-rays and measured, in centimeters, to grade severity. This test is done bilaterally

  9 months

• Severity of Gleno-humeral Subluxation

  This is a routine exam performed to assess shoulder subluxation. The space between the glenoid and head of the humerus can be visualized on plain X-rays and measured, in centimeters, to grade severity. This test is done bilaterally

  12 months

• Modified Ashworth Scale

  This is a routine exam performed for people with spinal cord injury.The Modified Ashworth Scale assesses muscle resistance to passive movement. The evaluator moves the joint through the available range of motion and assigns a score from 0-4, where 0 is no tone and 4 is fixed limb (ordinal scale, \[44\]).Subjects are tested in a seated position preferably in their wheelchairs. The subjects' upper extremity is stabilized by the examiner above and below the joint to be tested. Then the joint is quickly moved through the previously determined subjects' maximum range of motion

  Baseline, 4 months, 5 months, 9 months, 12 months

• Capabilities of the Upper Extremity (CUE) Test

  This is a routine exam performed for people with spinal cord injury.The CUE test is a 32-item interview. It is designed to self-assess upper extremity performance on a 7-point scale (nominal scale, \[45\]).Subjects are questioned while sitting in their wheelchairs. A brief description of the test will be read to the subjects and then questions asked, one at a time. Subjects will give verbal responses on a 7-point likert scale. total score possible is 0- 225, higher the score better outcome

  Baseline, 4 months, 5 months, 9 months, 12 months

• Jebsen-Taylor Hand Function (JTHF) Test

  This is a routine exam performed for people with spinal cord injury.The JTHF test is a 7-item test designed to objectively assess various hand functions and speed of performance (ordinal scale, \[46\]). Subjects are tested in a seated position, preferably from their wheelchairs, in front of a table. Test items will be laid out on the table and the test conducted per the standardized instructions. The JTHF requires subjects to reach for, lift, and in some cases manipulate small objects. smallest time in seconds mean a better outcome

  Baseline, 4 months, 5 months, 9 months, 12 months

• Box and Blocks (BB) Test

  This is a routine exam performed for people with spinal cord injury. The BB assesses gross hand function. Subjects are tested in a seated position, preferably from their wheelchairs, in front of a table. Test items will be laid out on the table and the test conducted per the standardized instructions. The BB requires subjects to reach for, lift, and move one inch cubes across a divider inside a wooden box. The amount of time (seconds) subject is able to move around is measured. Higher scores mean better outcome by timed test.

  Baseline, 4 months, 5 months, 9 months, 12 months

Secondary Outcomes (3)

• Action Research Arm (ARA) Test

  Baseline, 4 months, 5 months, 9 months, 12 months

• Range of Motion

  Baseline, 4 months, 5 months, 9 months, 12 months

• Numerical Rating Scale (NRS).

  Baseline, 4 months, 5 months, 9 months, 12 months

Study Arms (2)

No FES Cycling

SHAM COMPARATOR

Device: Non-FES Upper Extremity Exercise

FES Cycling

ACTIVE COMPARATOR

Device: RT300-SLSA, from Restorative Therapies, Inc.

Interventions

Non-FES Upper Extremity Exercise DEVICE

While undergoing the non-FES exercise intervention, the subjects will receive a specific, individualized exercise regimen, consisting of strengthening, stretching, splinting and any other therapeutic interventions that do not use electrical stimulation. Than a 1 month washout period,the subjects will remain seated in their primary wheelchair throughout the treatment. The subjects will exercise for 60 minutes/session, three times a week for 4 months.

No FES Cycling

RT300-SLSA, from Restorative Therapies, Inc. DEVICE

They will undergo 4 months of FES assisted upper extremity ergometry followed by 1 month was out period, than by 4 months of a specific, individualized, non FES assisted exercise regimen

FES Cycling

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male, Female, age 18-55, all ethnic groups
• Spinal Cord Injury, traumatic and non-traumatic
• C1-C6 neurological level
• ASIA class A-B
• Chronic injury \> 12 months and \< 20 years from the injury
• No upper-extremity electrical stimulation in the previous 4 weeks
• Subjects are medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues
• Baseline physical activity is kept stable
• Pain and antispasticity medications dose are kept stable
• Subjects are legally able to make their own health care decisions

You may not qualify if:

• Associated lower motor neuron/peripheral nerve injury in the C1-C6 levels
• Presence of pacemaker
• Presence of cancer
• History of seizures
• Women who are pregnant

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Cristina Sadowsky
• Organization: Kennedy Krieger institute

sadowsky@kennedykrieger.org

443-923-9232

Study Officials

• Cristina L Sadowsky, MD

  Kennedy Krieger

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Paralysis Restoration Clinic, International Center for Spinal Cord Injury, Kennedy Krieger Institute; Assistant Professor, Johns Hopkins University School of Medicine

Study Record Dates

• First Submitted: October 29, 2009
• First Posted: November 2, 2009
• Study Start: September 1, 2009
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: January 5, 2023
• Results First Posted: January 5, 2023

Record last verified: 2022-12

Locations

US (1)