Functional Electrical Stimulation (FES) Assisted Walking: Enhancement of Walking Function After Stroke
Palabras clave
Abstracto
Descripción
A stroke is a devastating life event, that can result in permanent disability. Many people who survive a stroke will experience paralysis on one side of their body. The muscles in one leg may become weaker or stiff to the point that the person can barely walk. Functional electrical stimulation (FES) is an intervention that applies short current pulses to muscles and causes them to contract. Previous work done by our team has used FES in the spinal cord injured population to help restore functions such as walking and grasping by contracting groups of paralyzed muscles in an orchestrated manner. This study seeks to explore whether a thrice weekly FES-assisted walking intervention for a 8 week period can stimulate or improve walking ability in individuals with severe lower extremity paralysis secondary to a stroke. This will subsequently promote opportunities for enhanced social participation and quality of life i.e. enhanced balance, increased independence of activities of daily living etc. for stroke consumers. Comparison: 40 individuals with severe hemiplegia will be randomized to either a thrice weekly control (false) FES training regimen OR a thrice weekly intervention (true) FES training regimen. Prior to randomization, participants will be stratified according to their ability to ambulate (walk). This study will determine if FES can improve or enhance walking ability associated with stroke after 8 weeks of training, and after 4-month follow-up period.
fechas
| Verificado por última vez: | 07/31/2008 |
| Primero enviado: | 10/31/2007 |
| Inscripción estimada enviada: | 10/31/2007 |
| Publicado por primera vez: | 11/01/2007 |
| Última actualización enviada: | 08/18/2008 |
| Última actualización publicada: | 08/19/2008 |
| Fecha de inicio real del estudio: | 09/30/2007 |
| Fecha estimada de finalización primaria: | 09/30/2010 |
| Fecha estimada de finalización del estudio: | 10/31/2010 |
Condición o enfermedad
Intervención / tratamiento
Device: 2
Device: 1
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Other: 1 Participants will be randomized to either an intervention arm where they will receive 'true' FES and the other control arm where they will receive 'false' FES. The sham group will receive 'false' FES. | Device: 1 'False' FES |
| Other: 2 The intervention group will receive 'true' FES | Device: 2 'True' Functional Electrical Stimulation Assisted Walking |
Criterio de elegibilidad
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - Hemiplegic stroke at least 12 months prior to joining the study. - Age 65 years or greater. - Ability to follow instructions and to devote his/her attention to therapy. - Ability to understand instructions in English and able to provide informed consent. Exclusion Criteria: - Severe difficulties with attention such that informed consent cannot be obtained, or that safety or communication would be comprised. - Ability to walk more that 10 meters during a two minute walk with an average speed greater than 0.8 m/s. - The presence of skin rashes, allergies or bruises where electrodes would be placed. - History of seizures, edema in paralyzed limbs or co-morbidities such as Parkinson's Disease, cancer or osteoarthritis to be confirmed by attending physiatrist. |
Salir
Medidas de resultado primarias
1. The ability of FES-Assisted Walking to stimulate or improve walking ability using a dichotomous outcome i.e. yes/no stimulation or improvement of walking ability on a two-minute walk test. [Test performed weekly during 8-week period as well as at 2 month and 6 month time point.]
Medidas de resultado secundarias
1. Assessment of balance by completing four tests i.e. move from a seated to a standing position, completion of activities of daily living tasks such as moving from a bed to a wheelchair, standing with eyes opened and closed. [Baseline, 2 month and 6 month period.]
2. Bone density at hip, spine, proximal tibia and distal femur using dual-energy xray absorptiometry [Baseline, 2-month and 6-month]
3. Assess functional abilities by performing various tasks using our leg and foot as well as your ability to perform functional tasks such as eating, grooming and bathing. [Baseline, 2-month and 6-month time points.]
