The Therapeutic Effects of Peroneal Nerve Functional Electric Stimulation for Lower Extremity in Patients With Sub-acute Post-stroke Hemiplegia "RALLY"

Recruiting

Phase N/A Results N/A

Trial Description

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.

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

Conditions

Interventions

  • Control Other
    Intervention Desc: Conventional rehabilitation therapy and gait training without WA.
    ARM 1: Kind: Experimental
    Label: Control
  • WA group Device
    Intervention Desc: Conventional rehabilitation therapy and gait training with WAIntervention with WA is scheduled 40min/day, five times a week, for 8 weeks.
    ARM 1: Kind: Experimental
    Label: WA

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary maximum walking distance of 6 Minute Walk Test (bare feet) 8weeks No
Secondary maximum walking distance of 6 Minute Walk Test (with WA) 8weeks No
Secondary maximum walking distance of 6 Minute Walk Test (with AFO) 8weeks No
Secondary walking speed of 10 Meter Walk Test (bare feet) 8weeks No
Secondary walking speed of 10 Meter Walk Test (with WA) 8weeks No
Secondary walking speed of 10 Meter Walk Test (with AFO) 8weeks No
Secondary Fugl-Meyer assessment (FMA) 8weeks No
Secondary modified Ashworth scale (MAS) 8weeks No
Secondary range of motion 8weeks No
Secondary Timed up and go test (bere feet) 8weeks No
Secondary Timed up and go test (with AFO) 8weeks No
Secondary Timed up and go test (with WA) 8weeks No
Secondary Stroke Impact Scale (SIS) 8weeks No
Secondary Patient reported outcome measure (PRO) 8weeks No
Secondary gait analysis by medical staff 8weeks No
Secondary Adverse event assessment 8weeks Yes

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