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

Gait training assisted by dual-channel functional electrical stimulation in early stroke rehabilitation: a proof-of-principle RCT - GAFESS (Gait training Assisted by FES in Stroke rehabilitation)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45202
Enrollment
70
Registered
2014-11-10
Start date
2014-11-20
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Vascular Accident stroke

Interventions

Additional to standard gait training during inpatient stroke rehabilitation, subjects in the intervention group receive DFES-assisted gait training for one 30-minute session each workday, during max

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Stride length symmetry ratio (spatial parameter) assessed with the SGAS.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)