Robotic Versus Conventional Training on Hemiplegic Gait. (BB200810)

Prasat Neurological Institute

Status and phase: Completed; Phase 3

Conditions: Stroke

Treatments: Device: conventional plus robotic gait assisted therapy; Behavioral: conventional therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01187277

BB200810

Details and patient eligibility

About

The incidence of stroke in the industrial world is still high. Most of the patients are suffering from paresis of the affected side, speech and cognition problems. Modern concepts of motor learning after stroke favouring a task-specific repetitive high-intensity therapy approach to promote motor outcome. In the last couple of years robot-assisted therapy became an important part of modern rehabilitation after stroke. But so far there is no clear evidence that robot assisted therapy in combination with conventional therapy is more effective than conventional therapy alone to promote motor functions after stroke.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subacute first-time stroke patients(hemorrhage and ischemic)
• Age 18-80 years.
• Impaired Functional Ambulation Category at initial score 0-2
• Cardiovascular stable
• Given signed inform consent

Exclusion criteria

• Unstable general medical condition

• Severe malposition or fixed contracture of joint with an extension deficit of more than 30 degree

• Any functional impairment prior to stroke

• Can not adequately cooperate in training

  • Severe communication problems
  • Severe cognitive - perceptual deficits

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

Group A

Experimental group

Description:

Group A = conventional therapy means: 50 min individual physiotherapy and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks

Treatment:

Behavioral: conventional therapy

Group B

Active Comparator group

Description:

Group B = conventional therapy plus robot-assisted means: 30 min individual physiotherapy plus 20 min robot-assisted gait training and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks

Treatment:

Device: conventional plus robotic gait assisted therapy