Gait therapy assisted by dual-channel functional electrical stimulation in early stroke rehabilitation: a proof-of-principle RCT
- Conditions
- Keywords in English: FES, electric stimulation, stroke, gait disorders, rehabilitation Keywords in Dutch: functionele elektrostimulatie, beroerte, gangbeeldlopen, spatiotemporele parameters, revalidatie
- Registration Number
- NL-OMON25761
- Lead Sponsor
- AMC and Merem Rehabilitation Centre De Trappenberg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
clinical diagnosis of stroke (diagnostic criteria according to the World Health Organisation definition);
- In the sub-acute stage of stroke (within 31 days since stroke onset);
- 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, self reported maximum walking distance <300 meter or walking duration <6 minutes walking pre-stroke);
- 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;
- a present or suspected cancerous lesion at the affected lower extremity;
- severe spasticity of the knee and ankle flexors and extensors (i.e., modified Ashworth Scale (mAS) =3)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gait symmetry (Stride length symmetry ratio)<br>
- Secondary Outcome Measures
Name Time Method Spatiotemporal parameters (stance time, swing time, double support, swing:stance time, ratios, step length, stride length), EMG, Gait Assessment and Intervention Tool, Edinburgh Gait Score, Berg Balance Scale, comfortable Ten Meter Walking Test, Physiological Cost Index, Functional Gait Assessment, Functional Ambulation Categories, Timed Up and Go test, Six Minutes Walking Test, patient satisfaction