Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-27 @ 1:57 PM
Study NCT ID:
NCT02898168
Status:
COMPLETED
Last Update Posted:
2020-06-17
First Post:
2016-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Therapeutic Effects of Peroneal Nerve Functional Electrical Stimulation for Lower Extremity in Patients With Sub-acute Post-stroke Hemiplegia
Sponsor:
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Organization:
Study Overview
Official Title:
The Therapeutic Effects of Peroneal Nerve Functional Electrical Stimulation for Lower Extremity in Patients With Sub-acute Post-stroke Hemiplegia A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RALLY
Brief Summary:
Among the sequelae of stroke, gait disorder is directly linked to the degree of autonomy in the daily life of patients. It is considered significant effects on their Quality of Life(QOL).
Further methods of rehabilitation are required for convalescent patients to recover their function soon and better, due to a multitudes of recovery patient with troubles such as gait problem.
This trial is studying to investigate the effects of gait training with a functional electrical stimulation (FES) 'WalkAide\[R\](WA)' to improve the lower-limb function and ambulation in convalescent stroke patients.
Further methods of rehabilitation are required for convalescent patients to recover their function soon and better, due to a multitudes of recovery patient with troubles such as gait problem.
This trial is studying to investigate the effects of gait training with a functional electrical stimulation (FES) 'WalkAide\[R\](WA)' to improve the lower-limb function and ambulation in convalescent stroke patients.
Detailed Description:
This study is targeting convalescent patients within 6 months after the onset of initial stroke (cerebral infarction or cerebral hemorrhage) and also observing the foot drop during walking.
Some study for the patients after the onset of stroke (over several months) are reported that a case of the efficacy by the treatment using the FES, and another case of using FES indicated the equal efficacy and the higher QOL compared to using ankle-foot orthosis(AFO).
However, these are clinical research results overseas and there are not so many studies targeting only for convalescent stroke patients.
FES which recover the lost function by paralysis using electrical stimulation is recommended as convalescent rehabilitation by Japanese Guidelines for the Management of Stroke 2015 etc..
The purpose of FES treatment is the electrical stimulation to peroneal nerve of patients with foot drop and equinus foot due to central nervous system damage and the objective efficacy is following:
* To improve the walking by dorsiflexing the foot during swing phase
* To prevention and suppression of disuse atrophy
* To increase local blood flow
* To re-educate muscle
* To maintain or increase the range of joint motion
Some study for the patients after the onset of stroke (over several months) are reported that a case of the efficacy by the treatment using the FES, and another case of using FES indicated the equal efficacy and the higher QOL compared to using ankle-foot orthosis(AFO).
However, these are clinical research results overseas and there are not so many studies targeting only for convalescent stroke patients.
FES which recover the lost function by paralysis using electrical stimulation is recommended as convalescent rehabilitation by Japanese Guidelines for the Management of Stroke 2015 etc..
The purpose of FES treatment is the electrical stimulation to peroneal nerve of patients with foot drop and equinus foot due to central nervous system damage and the objective efficacy is following:
* To improve the walking by dorsiflexing the foot during swing phase
* To prevention and suppression of disuse atrophy
* To increase local blood flow
* To re-educate muscle
* To maintain or increase the range of joint motion
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| UMIN-CTR | OTHER | UMIN000020604 | View |