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Clinical Trials/CTRI/2012/02/002412
CTRI/2012/02/002412
Completed
未知

A Comparative, Randomized, Double-blind Pilot Study to Evaluate Re-learning of Ankle function after an intensive 2-week Gait Re-training with Electromyogram (EMG)-triggered or Footswitch (SW)-trigger Functional Electrical Stimulation (FES) in Chronic Stroke patients with foot drop

Department of Physiotherapy and RehabilitationMSSHwest0 sites20 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: null- Chronic Stroke Patients
Sponsor
Department of Physiotherapy and RehabilitationMSSHwest
Enrollment
20
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Department of Physiotherapy and RehabilitationMSSHwest

Eligibility Criteria

Inclusion Criteria

  • \>6 months from a first clinical non\-hemorrhagic or hemorrhagic stroke
  • Medically stable
  • Unilateral lower extremity hemi paresis
  • Ankle dorsiflexor strength of \<\=4/5 on the MRC scale, while seated
  • Able to ambulate 16 feet (5 meters) continuously with minimal assistance or less, without the use of an AFO.
  • AFO is clinically indicated (foot drop during ambulation or inefficient gait patterns)
  • NMES of the paretic ankle dorsiflexors produces ankle dorsiflexion to neutral without pain.
  • Full voluntary dorsiflexion of the contralateral ankle
  • Skin intact on hemiparetic lower extremity
  • Able to don the FES system.

Exclusion Criteria

  • Brainstem stroke
  • Severely impaired cognition and communication
  • History of peroneal nerve injury
  • History of Parkinsons, SCI, TBI, or multiple sclerosis, Uncontrolled seizure disorder
  • Uncompensated hemi\-neglect (extinguishing to double simultaneous stimulation)
  • Edema of the affected lower extremity
  • Absent sensation of lower leg and foot
  • Evidence of deep venous thrombosis or thromboembolism
  • History of cardiac arrhythmias with hemodynamic instability
  • Cardiac pacemaker or other implanted electronic system

Outcomes

Primary Outcomes

Not specified

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