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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25761
Enrollment
40
Registered
2014-08-28
Start date
2014-11-24
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Keywords in English: FES, electric stimulation, stroke, gait disorders, rehabilitation Keywords in Dutch: functionele elektrostimulatie, beroerte, gangbeeld lopen, spatiotemporele parameters, revalidatie

Interventions

Intervention group: Ten weeks, five days per week, one 30-minute gait therapy session a day (usual care) in which gait is assisted by functional electrical stimulation with a dual-channel device (NESS
Plus). Control group: usual care.

Sponsors

AMC and Merem Rehabilitation Centre De Trappenberg
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - 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); - 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.

Exclusion criteria

Exclusion criteria: - 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)

Design outcomes

Primary

MeasureTime frame
Gait symmetry (Stride length symmetry ratio)

Secondary

MeasureTime frame
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

Contacts

Public ContactM. Bloemendaal, van

-

mbloemendaal@trappenberg.merem.nl+31 (0)35-6929610

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)