Back to resultsPatterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury
Primary Purpose
Spinal Cord Injury
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Non-FES Upper Extremity Exercise
RT300-SLSA, from Restorative Therapies, Inc.
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury
Eligibility 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
Sites / Locations
- Kennedy Krieger Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
No FES Cycling
FES Cycling
Arm Description
Outcomes
Primary Outcome Measures
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
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
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
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
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
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
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
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.
Secondary Outcome Measures
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
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
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
Full Information
NCT ID
NCT01005615
First Posted
October 29, 2009
Last Updated
December 12, 2022
Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
U.S. Army Medical Research and Development Command
1. Study Identification
Unique Protocol Identification Number
NCT01005615
Brief Title
Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury
Official Title
Advanced Restoration Therapies in Spinal Cord Injury. AIM1: Patterned FES Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Terminated
Why Stopped
Funding expired and we were unable to gain new funding
Study Start Date
September 2009 (undefined)
Primary Completion Date
January 2021 (Actual)
Study Completion Date
January 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Collaborators
U.S. Army Medical Research and Development Command
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No FES Cycling
Arm Type
Sham Comparator
Arm Title
FES Cycling
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Non-FES Upper Extremity Exercise
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
RT300-SLSA, from Restorative Therapies, Inc.
Intervention Description
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
Primary Outcome Measure Information:
Title
Severity of Gleno-humeral Subluxation
Description
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
Time Frame
Baseline
Title
Severity of Gleno-humeral Subluxation
Description
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
Time Frame
4 months
Title
Severity of Gleno-humeral Subluxation
Description
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
Time Frame
9 months
Title
Severity of Gleno-humeral Subluxation
Description
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
Time Frame
12 months
Title
Modified Ashworth Scale
Description
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
Time Frame
Baseline, 4 months, 5 months, 9 months, 12 months
Title
Capabilities of the Upper Extremity (CUE) Test
Description
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
Time Frame
Baseline, 4 months, 5 months, 9 months, 12 months
Title
Jebsen-Taylor Hand Function (JTHF) Test
Description
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
Time Frame
Baseline, 4 months, 5 months, 9 months, 12 months
Title
Box and Blocks (BB) Test
Description
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.
Time Frame
Baseline, 4 months, 5 months, 9 months, 12 months
Secondary Outcome Measure Information:
Title
Action Research Arm (ARA) Test
Description
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
Time Frame
Baseline, 4 months, 5 months, 9 months, 12 months
Title
Range of Motion
Description
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
Time Frame
Baseline, 4 months, 5 months, 9 months, 12 months
Title
Numerical Rating Scale (NRS).
Description
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
Time Frame
Baseline, 4 months, 5 months, 9 months, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina L Sadowsky, MD
Organizational Affiliation
Kennedy Krieger
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.spinalcordrecovery.org/
Description
Related Info
Learn more about this trial
Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury
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