Robotic Versus Conventional Training on Hemiplegic Gait.

A Randomized Controlled Trial on Hemiplegic Gait Rehabilitation: Robotic Locomotor Training Versus Conventional Training in Subacute Stroke.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01187277

Acronym

BB200810

Enrollment

Registered

2010-08-24

Start date

2011-01-31

Completion date

2012-07-31

Last updated

2012-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

stroke, rehabilitation, gait training, robot-assisted therapy

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.

Interventions

BEHAVIORALconventional therapy

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

DEVICEconventional plus robotic gait assisted therapy

individual physiotherapy +individual occupational therapy+ robotic gait assisted therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026