To investigate the feasibility of a 10 week (maximum) gait training with DFES in rehabilitation starting in the sub-acute phase after stroke and the initial efficacy on the recovery of spatiotemporal parameters, gait kinetics and kinematics,…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Stride length symmetry ratio (spatial parameter) assessed with the SGAS.
Secondary outcome
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.
Background summary
Many patients after stroke suffer from reduced walking ability because of
pareses of lower extremity muscles. Functional electrical stimulation (FES) has
been used to improve walking ability but evidence is limited to peroneal FES,
which only stimulates the distal part of the lower extremity. A recently
developed device, the NESS L300* Plus, is a lower extremity dual-channel FES
(DFES) system, activating proximal as well as distal muscle groups of the lower
extremity. Evidence for effectiveness in stroke rehabilitation is lacking. The
use of DFES in the early gait rehabilitation after stroke may enhance gait
efficiency.
Study objective
To investigate the feasibility of a 10 week (maximum) gait training with DFES
in rehabilitation starting in the sub-acute phase after stroke and the initial
efficacy on the recovery of spatiotemporal parameters, gait kinetics and
kinematics, functional ambulation, walking ability and mobility. And to assess
validity and reliability of the spatiotemporal gait analysis system (SGAS).
Study design
A proof-of-principle randomized clinical trial and a cross-sectional study.
Intervention
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 maximal 10 weeks.
Study burden and risks
The burden related to study participation of the patients consists of time and
effort invested in the assessments at baseline, every two weeks during the
intervention period and the two follow up assessments. Subjects in the
intervention group may perceive some discomfort from electrical stimulation but
this will be transient and subjects will probably adapt to this. A risk of
participation is skin problems at the site of the stimulation electrodes from
the stimulation. Therefore, the intervention starts with an adaptation period.
The study burden for the healthy subjects consists of repeated walking
assessments during a single visit.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 19364 |
| CCMO | NL50002.018.14 |