A novel interactive exoskeleton robotic system with embedded force and motion sensors will be developed to facilitate walking of stroke patients with hemiparesis. The robot will synchronise with the gait pattern of the stroke patient to provide assistance in ankle dorsiflexion during swing phase. It is hypothesised that the robot can facilitate stable and longer walking distance for stroke patients with drop foot problem. It can be applied on unilateral side, which is suitable for stroke patients with hemiparesis. The whole system design is lightweight, compact, comfortable, and user-friendly in hospital or at home settings.
In this clinical trial, participated stroke patients will be divided into two groups: Robotic group and Sham group. Stroke patients in both groups will participate in a 20-session gait training program, which includes overground walking and stair climbing exercises. Robotic group will walk with the powered Ankle Robot, which provide ankle dorsiflexion support during swing phase of walking; Sham group will walk with the Ankle Robot with very low assistance level, which provide only tactile feedback but no ankle support in order to evaluate the placebo effect. A series of clinical assessments will be carried out to assess the functional recovery in stroke patients before and after the gait training program.
- Sham Device
Intervention Desc: Stroke patients will enrol in a 20-session gait training program for at least two sessions per week. In each session, the stroke patient will walk overground continuously for 2 * 10 minutes and walk up/down a staircase (about 10 steps per flight) for 10 minutes, rest will be provided in between each round of walking or stair climbing. This training can promote physical fitness. They will wear the Ankle Robot during the gait training. The robot will synchronise with the paretic-side gait pattern to the Ankle Robot provides very low assistance which can be barely perceived by the stroke patient but does not suffice to support the ankle dorsiflexion. ARM 1: Kind: Experimental Label: Sham group Description: In this sham group, the Ankle Robot provides very low assistance to generate tactile feedback to the stroke patients indicating they are performing the swing phase gait movement, but no assistance will be given to support their ankle dorsiflexion.
- Ankle robot Device
Intervention Desc: An exoskeleton ankle robot is developed to correct the drop foot problem of the stroke patients or the elderly with muscle weakness at the ankle joint. ARM 1: Kind: Experimental Label: Ankle robot
- Ankle Robot with Power Assistance Device
Intervention Desc: Stroke patients will enrol in a 20-session gait training program for at least two sessions per week. In each session, the stroke patient will walk overground continuously for 2 * 10 minutes and walk up/down a staircase (about 10 steps per flight) for 10 minutes, rest will be provided in between each round of walking or stair climbing. This training can promote gait recovery and physical fitness. They will wear the Ankle Robot during the gait training. The motor will synchronise with the paretic-side gait pattern to provide dorsiflexion moment during swing phase, and free the ankle joint when the sole is loaded. ARM 1: Kind: Experimental Label: Ankle Robot with Power Assistance Description: In this experimental group, the Ankle Robot assists the ankle dorsiflexion when the stroke patients voluntarily perform the swing phase gait movement.
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Fugl-Meyer Assessment Lower Extremity||3-month follow-up||No|
|Primary||Timed 10-meter Walk Test||3-month follow-up||No|
|Primary||6-minute Walk Test||3-month follow-up||No|
|Secondary||Kinematic and Kinetic Gait Motion Capture||3-month follow-up||No|
|Secondary||Functional Ambulation Category||3-month follow-up||No|
|Secondary||Modified Ashworth Scale||3-month follow-up||No|
|Secondary||Berg Balance Scale||3-month follow-up||No|
|Secondary||Timed 10 Meter Walk Test||3-month follow-up||No|
|Secondary||Fugl-Meyer Assessment of Motor Recovery after Stroke (Lower Extremity)||3-month follow-up||No|
|Secondary||Subjective Feedback Questionnaire||3-month follow-up||No|