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

• ClinicalTrials.gov Identifier: NCT01005615
• Recruitment Status: Terminated
• First Posted: November 1, 2009
• Results First Posted: January 5, 2023
• Last Update Posted: January 5, 2023
• Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• Collaborator: U.S. Army Medical Research and Development Command
• Information provided by (Responsible Party): Cristina Sadowsky, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Spinal Cord Injury	Device: Non-FES Upper Extremity Exercise; Device: RT300-SLSA, from Restorative Therapies, Inc.	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Advanced Restoration Therapies in Spinal Cord Injury. AIM1: Patterned FES Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury
• Study Start Date: September 2009
• Actual Primary Completion Date: January 2021
• Actual Study Completion Date: January 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Severity of Gleno-humeral Subluxation [ Time Frame: Baseline ]
   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
2. Severity of Gleno-humeral Subluxation [ Time Frame: 4 months ]
   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
3. Severity of Gleno-humeral Subluxation [ Time Frame: 9 months ]
   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. Severity of Gleno-humeral Subluxation [ Time Frame: 12 months ]
   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
5. Modified Ashworth Scale [ Time Frame: Baseline, 4 months, 5 months, 9 months, 12 months ]
   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
6. Capabilities of the Upper Extremity (CUE) Test [ Time Frame: Baseline, 4 months, 5 months, 9 months, 12 months ]
   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
7. Jebsen-Taylor Hand Function (JTHF) Test [ Time Frame: Baseline, 4 months, 5 months, 9 months, 12 months ]
   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
8. Box and Blocks (BB) Test [ Time Frame: Baseline, 4 months, 5 months, 9 months, 12 months ]
   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.

Secondary Outcome Measures :

1. Action Research Arm (ARA) Test [ Time Frame: Baseline, 4 months, 5 months, 9 months, 12 months ]
   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
2. Range of Motion [ Time Frame: Baseline, 4 months, 5 months, 9 months, 12 months ]
   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
3. Numerical Rating Scale (NRS). [ Time Frame: Baseline, 4 months, 5 months, 9 months, 12 months ]
   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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Maryland

Kennedy Krieger Institute

Baltimore, Maryland, United States, 21205

Sponsors and Collaborators

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

U.S. Army Medical Research and Development Command

Investigators

• Principal Investigator: Cristina L Sadowsky, MD; Kennedy Krieger

  Study Documents (Full-Text)

Documents provided by Cristina Sadowsky, M.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] September 16, 2013

More Information

Additional Information:

Related Info 

• Responsible Party: Cristina Sadowsky, M.D., Director, Paralysis Restoration Clinic, International Center for Spinal Cord Injury, Kennedy Krieger Institute; Assistant Professor, Johns Hopkins University School of Medicine, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
• ClinicalTrials.gov Identifier: NCT01005615
• Other Study ID Numbers: NA_00014481; w81xwh-08-2-0192; W81XWH-09-2-0186
• First Posted: November 1, 2009
• Results First Posted: January 5, 2023
• Last Update Posted: January 5, 2023
• Last Verified: December 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

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