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

Advanced Restoration Therapies in Spinal Cord Injury. AIM1: Patterned FES Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury

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.

Study Overview

• Status: Terminated
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Device: Non-FES Upper Extremity Exercise; Device: RT300-SLSA, from Restorative Therapies, Inc.

Detailed Description

A randomized, controlled, single-blinded, in-subject controlled (A-B type) trial will be performed in patients with SCI receiving an upper extremities non-FES assisted exercise protocol compared with patients receiving upper extremities ergometry in combination with FES. Neurological and functional outcome measures will be obtained at baseline (time 0), after 1st 4 months of intervention (4 months), after 1 month washout (5 months),after 2nd 4 months intervention (9 months), and 3 month after completing the last intervention (12 months).

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Kennedy Krieger Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: No FES Cycling	Device: Non-FES Upper Extremity Exercise; 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.
Active Comparator: FES Cycling	Device: RT300-SLSA, from Restorative Therapies, Inc.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Action Research Arm (ARA) Test	This is a routine exam performed for people with spinal cord injury.The ARA test observationally assesses upper extremity 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 ARA requires subjects to handle objects differing in size, weight and shape. Score range is from 0-57, higher the number means better outcome overall	Baseline, 4 months, 5 months, 9 months, 12 months
Range of Motion	This is a routine exam performed for people with spinal cord injury. Subjects are tested in a seated position, preferably in their wheelchairs. The desired joint is isolated and moved through the maximum available range of motion. Once the end range is reached, joint excursion is measured with a goniometer. This measure is to see if you have any active range of motion. 1 is yes to active range of motion and 0 is no range of motion. Having active range of motion is a better outcome	Baseline, 4 months, 5 months, 9 months, 12 months
Numerical Rating Scale (NRS).	This is a routine exam performed for people with spinal cord injury. Subjects report how much pain they are having by choosing a number from 0-10, 0 being no pain and 10 being the worst pain	Baseline, 4 months, 5 months, 9 months, 12 months

Collaborators and Investigators

• Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Collaborators: U.S. Army Medical Research and Development Command
• Investigators: Principal Investigator: Cristina L Sadowsky, MD, Kennedy Krieger

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: October 29, 2009
• First Submitted That Met QC Criteria: October 30, 2009
• First Posted (Estimate): November 1, 2009

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: NA_00014481; w81xwh-08-2-0192; W81XWH-09-2-0186

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes