Gait training assisted by dual-channel functional electrical stimulation in early stroke rehabilitation: a proof-of-principle RCT

Completed

Conditions: Cerebral Vascular Accident
stroke
10007963

Registration Number: NL-OMON45202

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 70

Inclusion Criteria

Patients:
- clinical diagnosis of stroke (diagnostic criteria according to the World Health Organisation definition);
- 14-31 days since stroke onset;
- age between 18 and 80 years old;
- referred to inpatient rehabilitation;
- medically stable and able to follow an intensive rehabilitation program;
- indication for gait training;
- sufficient power to stand in parallel bars with or without physical assistance;
- passive range of motion (PROM) ankle dorsiflexion of at least 0 degrees at full knee extension.;Healthy subjects:
- age between 18 and 80 years old;
- healthy (self-reported); and
- no gait deficits due to diagnosed medical conditions.

Exclusion Criteria

Patients:
- subarachnoid hemorrhage;
- stroke in the cerebellum or brain stem;
- pre-existing lower extremity deficits or any other medical co morbidities that interfere significantly with gait;
- severe cognitive problems or aphasia with severely impaired comprehension of test instructions;
- medical conditions that prevents participation or will lead to inability to comply with the protocol (e.g., congestive heart failure, patient receiving chemotherapy, uncontrolled epilepsy, pregnancy, depression or a psychotic disorder, etc.);
- a demand-type cardiac pacemaker, defibrillator or any electrical implant;
- a metallic implant at the affected lower extremity; or
- a present or suspected cancerous lesion at the affected lower extremity.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Stride length symmetry ratio (spatial parameter) assessed with the SGAS.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other spatiotemporal parameters (timing stance and swing phase, double support<br /><br>time, swing:stance time, ratios, step length, gait speed), EMG, functional<br /><br>walking ability, balance and patient satisfaction.<br /><br>Measurement properties of the SGAS: concurrent validity and inter- and<br /><br>intra-rater reliability.</p><br>