Clinical trial NCT02755415: Clinical Applicability of Robot-assisted Gait Training System in Acute Stroke Patients
Official title: Clinical Applicability of Robot-assisted Gait Training System in Acute Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Rehabilitation
Robotic
Gait
Quality of Life
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2016-04-28
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted gait training system for acute stroke survivors. It is anticipated that robot-assisted gait rehabilitation will achieve significantly better gait and quality of life outcomes than the standing table rehabilitation.

Detailed description: Stroke is not only the second leading cause of mortality in Taiwan, it is also the primary cause of long-term physical and psychological disabilities in our society. Array of reasons have been suggested to be an obstacle for stroke patients to receive adequate physical rehabilitation, including the lack of physical capacity, severe neurological deficits or the loss of strength. Given the critical importance of high-intensity and high-repetitiveness of early rehabilitation for stroke patients in achieving sustainable long term outcomes, robot-assisted gait rehabilitation devices have gained great interest in the last decade and is slowly becoming part of the clinical rehabilitation program for stroke patients. However, despite the growing interest and the significant resources invested for the development of robot-assisted rehabilitation devices, there still lacks empirical evidence of its clinical applicability for stroke patients. Moreover, available evidence to date have mostly focused on sub-acute and chronic stroke patients and investigation in acute stroke population, especially in those with complete incapacitation for ambulation, is sparse. It is therefore the aim of the proposed project to fulfil this significant gap in our clinical knowledge by comparatively investigate the clinical applicability of a recently developed HIWIN Robotic Gait Training System (MRG-P100) against the traditional rehabilitation program with an emphasis on the determination of psychological and functional capacity recovery status in acute stroke survivors.

Eligibility criteria: Inclusion Criteria:

* Between the age of 20-80 years;
* Diagnosis of first, single unilateral cortical-subcortical acute stroke verified by brain imaging;
* Paresis of a lower limb;
* Ability to walk for only a few meters either with or without aid.

Exclusion Criteria:

* Deemed by a physician to be medically unstable;
* Other prior musculoskeletal conditions that affected gait capacity;
* Co-existence of other neurological diseases;
* Cognitive impairments that would impact on the safe participation in the study (MMSE\<23)

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 15-20 minutes
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index
timeFrame: 10-15 minutes
measure: EuroQol five dimensions questionnaire (EQ-5D)
timeFrame: 10-15 minutes
measure: Resting muscle tone
timeFrame: 10 minutes
measure: Resting muscle elasticity
timeFrame: 10 minutes
measure: Six minute walk test
timeFrame: 6 minutes
measure: Beck's depression Inventory
timeFrame: 7-10 minutes
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: