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

• Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc. (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01005615
• Collaborator: U.S. Army Medical Research and Development Command (U.S. Fed)
• Enrollment: 18
• Location: 1
• Arms: 2
• Duration (Months): 136
• Patients Per Site Per Month: 0.1

Study Details

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
• Actual Enrollment: 18 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: Sep 1, 2009
• Actual Primary Completion Date: Jan 1, 2021
• Actual Study Completion Date: Jan 1, 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. X-ray [Initial, 4 months, 5 months, 9 months, 12 months]

2. Modified Ashworth scale [Initial, 4 months, 5 months, 9 months, 12 months]

3. Capabilities of the Upper Extremity (CUE) test [Initial, 4 months, 5 months, 9 months, 12 months]

4. Jebsen-Taylor Hand Function (JTHF) test [Initial, 4 months, 5 months, 9 months, 12 months]

5. Box and Blocks (BB) test [Initial, 4 months, 5 months, 9 months, 12 months]

Secondary Outcome Measures

1. Action Research Arm (ARA) test [Initial, 4 months, 5 months, 9 months, 12 months]

2. Range of motion [Initial, 4 months, 5 months, 9 months, 12 months]

3. Numerical Rating Scale (NRS). [Initial, 4 months, 5 months, 9 months, 12 months]

4. American Spinal Injury Association (ASIA) exam [Initial, 4 months, 5 months, 9 months, 12 months]

Eligibility Criteria

Criteria

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

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

	Site	City	State	Country	Postal Code
1	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)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• 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: Nov 1, 2009
• Last Update Posted: Jan 26, 2022
• Last Verified: Jan 1, 2022

• Additional relevant MeSH terms: Spinal Cord Injuries; Wounds and Injuries

Study Results

No Results Posted as of Jan 26, 2022