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

Last updated: October 10, 2024
Sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Injuries

Treatment

Robotic rehabilitation

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

Clinical Study ID

NCT06541197
AESH-EK1-2024-0088
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 acane or crutches.

  5. Signed informed consent form indicating willingness to participate in the study.

Exclusion

Exclusion Criteria:

  1. Severe spasticity or joint contracture in the lower extremities that impedesmovement.

  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 preventingexercise compliance, unstable epilepsy or unexplained convulsions, unstable acutecardiac arrhythmia or heart failure, presence of a cardiac pacemaker).

  7. Psychiatric disorders or cognitive problems that prevent completing questionnairesand assessment scales.

  8. Presence of other neurological or muscular diseases.

Study Design

Total Participants: 38
Treatment Group(s): 2
Primary Treatment: Robotic rehabilitation
Phase:
Study Start date:
August 26, 2024
Estimated Completion Date:
August 26, 2025

Study Description

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.

Connect with a study center

  • Ankara Gaziler Physical Medicine and Rehabilitation Education and Research Hospital

    Ankara,
    Turkey

    Active - Recruiting

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