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

NCT ID: NCT01005615

Last Updated: 2023-01-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2021-01-31

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).

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

No FES Cycling

Group Type: SHAM_COMPARATOR

Non-FES Upper Extremity Exercise

Intervention Type: 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.

FES Cycling

Group Type: ACTIVE_COMPARATOR

RT300-SLSA, from Restorative Therapies, Inc.

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristina L Sadowsky, MD

Role: PRINCIPAL_INVESTIGATOR

Kennedy Krieger

Locations

Kennedy Krieger Institute

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.spinalcordrecovery.org/

Related Info

Other Identifiers

w81xwh-08-2-0192

Identifier Type: -

Identifier Source: secondary_id

W81XWH-09-2-0186

Identifier Type: -

Identifier Source: secondary_id

NA_00014481

Identifier Type: -

Identifier Source: org_study_id