Robotic Versus Conventional Training on Hemiplegic Gait.

Phase 3

Completed

• Conditions: Stroke
• Interventions: Behavioral: conventional therapy; Device: conventional plus robotic gait assisted therapy

• Registration Number: NCT01187277
• Lead Sponsor: Prasat Neurological Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-20
• Study First Submitted QC: 2010-08-23
• Study First Posted: 2010-08-24
• Study Start: 2011-01
• Primary Completion: 2012-05
• Status Verified: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-07-15
• Last Update Posted: 2012-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	conventional therapy	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
Group B	conventional plus robotic gait assisted therapy	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

Primary Outcome Measures

Name	Time	Method
Functional Ambulation Categories (FAC, 0-5)	4 weeks	Description of ambulation level of the individual patient, whether and if, how much support is needed.
Barthel index (BI, 0-100)	4 weeks	Assesses independence in activity of daily living

Secondary Outcome Measures

Name	Time	Method
Berg Balance Scale (BBS, 0-56	4 weeks	Assesses balance abilities.
REPAS -Muscle tone (REPAS, 0-52)	4 weeks	Sum score to assess muscle tone for the major joints of the upper and lower extremities.

Trial Locations

Locations (1)

Prasat Neurological Institute; 🇹🇭 Bangkok, Thailand