The Effect of Functional Electrical Stimulation Cycling Ergometry in Addition to Robotic Rehabilitation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-09-05

Brief Summary

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Spinal cord injury (SCI) is a devastating neurological condition resulting from either traumatic or non-traumatic causes, leading to loss of motor, sensory, and autonomic functions in individuals. Statistics indicate that more than 75% of individuals with incomplete SCI regain some degree of ambulatory function.

Authors' aim in this study is to investigate the effect of adding functional electrical stimulation (FES) bicycle ergometry to robotic rehabilitation on lower extremity functional recovery and ambulation in patients with chronic incomplete SCI.

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Detailed Description

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Spinal cord injury (SCI) is a devastating neurological condition resulting from either traumatic or non-traumatic causes, leading to loss of motor, sensory, and autonomic functions in individuals. Statistics indicate that more than 75% of individuals with incomplete SCI regain some degree of ambulatory function. To the authors' knowledge, no other study has investigated the effect of adding FES bicycle ergometry to robotic rehabilitation on lower extremity functional recovery and ambulation in patients with chronic incomplete SCI. Authors' hypothesis is that the group receiving FES bicycle ergometry in addition to robotic rehabilitation will achieve better functional recovery and ambulation compared to the group receiving only robotic rehabilitation. In this context, authors' aim in this study is to investigate the effect of adding functional electrical stimulation bicycle ergometry to robotic rehabilitation on lower extremity functional recovery and ambulation in patients with chronic incomplete SCI.

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Robotic rehabilitation combined with Functional Electrical Stimulation (FES) bicycle ergometry group

Robotic assisted walking exercise will be performed in the walking exercise robot for a total of 20 sessions for 4 weeks. For FES bicycle ergometry, a current-controlled six-channel stimulator (RT 300-SLSA; Restorative Therapies, Baltimore, MD, USA) will be used. The quadriceps, hamstring and tibialis anterior muscles will be stimulated bilaterally with six channels through 3 × 4 cm2 adhesive surface electrodes. Stimulation intensity will be adjusted according to palpable muscle contraction and sensory discomfort felt by patients with incomplete SCI. The pedaling cadence range will be set to 40-50 rotations per minute. Robotic rehabilitation will be applied in 30-minute sessions with Lokomat v5 (Hocoma, Volketswil, Switzerland) device for lower extremity rehabilitation. FES bicycle ergometry will be performed in 30-minute sessions for 4 weeks for a total of 20 sessions under the supervision of a physician before robotic rehabilitation.

Group Type ACTIVE_COMPARATOR

Robotic rehabilitation combined with Functional Electrical Stimulation (FES) bicycle ergometry group

Intervention Type OTHER

Robotic rehabilitation will be applied in 30-minute sessions with Lokomat v5 (Hocoma, Volketswil, Switzerland) device for lower extremity rehabilitation. Robotic assisted walking exercise will be performed in the walking exercise robot for a total of 20 sessions for 4 weeks. For FES bicycle ergometry, a current-controlled six-channel stimulator (RT 300-SLSA; Restorative Therapies, Baltimore, MD, USA) will be used. The quadriceps, hamstring and tibialis anterior muscles will be stimulated bilaterally with six channels through 3 × 4 cm2 adhesive surface electrodes. Stimulation intensity will be adjusted according to palpable muscle contraction and sensory discomfort felt by patients with incomplete SCI. The pedaling cadence range will be set to 40-50 rotations per minute. FES bicycle ergometry will be performed in 30-minute sessions for 4 weeks for a total of 20 sessions before robotic rehabilitation.

Robotic rehabilitation

Robotic rehabilitation will be applied in 30-minute sessions with Lokomat v5 (Hocoma, Volketswil, Switzerland) device for lower extremity rehabilitation. Robotic assisted walking exercise will be performed in the walking exercise robot for a total of 20 sessions for 4 weeks.

Group Type ACTIVE_COMPARATOR

Robotic rehabilitation

Intervention Type OTHER

Robotic rehabilitation will be applied in 30-minute sessions with Lokomat v5 (Hocoma, Volketswil, Switzerland) device for lower extremity rehabilitation. Robotic assisted walking exercise will be performed in the walking exercise robot for a total of 20 sessions for 4 weeks.

Interventions

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Robotic rehabilitation combined with Functional Electrical Stimulation (FES) bicycle ergometry group

Robotic rehabilitation will be applied in 30-minute sessions with Lokomat v5 (Hocoma, Volketswil, Switzerland) device for lower extremity rehabilitation. Robotic assisted walking exercise will be performed in the walking exercise robot for a total of 20 sessions for 4 weeks. For FES bicycle ergometry, a current-controlled six-channel stimulator (RT 300-SLSA; Restorative Therapies, Baltimore, MD, USA) will be used. The quadriceps, hamstring and tibialis anterior muscles will be stimulated bilaterally with six channels through 3 × 4 cm2 adhesive surface electrodes. Stimulation intensity will be adjusted according to palpable muscle contraction and sensory discomfort felt by patients with incomplete SCI. The pedaling cadence range will be set to 40-50 rotations per minute. FES bicycle ergometry will be performed in 30-minute sessions for 4 weeks for a total of 20 sessions before robotic rehabilitation.

Intervention Type OTHER

Robotic rehabilitation

Robotic rehabilitation will be applied in 30-minute sessions with Lokomat v5 (Hocoma, Volketswil, Switzerland) device for lower extremity rehabilitation. Robotic assisted walking exercise will be performed in the walking exercise robot for a total of 20 sessions for 4 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Motor Incomplete spinal cord injury (ASIA C and D).
2. At least 6 months post spinal cord injury.
3. Age between 18 and 65 years.
4. Ability to walk at least 10 meters independently or with assistive devices such as a cane or crutches.
5. Signed informed consent form indicating willingness to participate in the study.

Exclusion Criteria

1. Severe spasticity or joint contracture in the lower extremities that impedes movement.
2. Presence of metallic implants in the lower extremities.
3. Stage 2 or higher pressure ulcers on the sacral or coccygeal regions.
4. Co-existing peripheral neuropathy.
5. Permanent urinary catheter use.
6. Contraindications for walking exercises (e.g., cognitive impairment preventing exercise compliance, unstable epilepsy or unexplained convulsions, unstable acute cardiac arrhythmia or heart failure, presence of a cardiac pacemaker).
7. Psychiatric disorders or cognitive problems that prevent completing questionnaires and assessment scales.
8. Presence of other neurological or muscular diseases.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No