Comparison Of Two Different Type Robot Assisted Gait Training In Rehabilitation Of Stroke

NCT ID: NCT03565185

Last Updated: 2020-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-30

Study Completion Date

2020-04-01

Brief Summary

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Investigators aimed to compare the results of rehabilitation with an exoskeleton device(Robogait) and with an end-effector device(Lokohelp)

Detailed Description

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There are different types of devices in robotic rehabilitation which has been used in recent years for stroke. Investigators aimed to compare the results of rehabilitation with an exoskeleton device(Robogait) and with an end-effector device(Lokohelp) in robot-assisted gait training of stroke rehabilitation

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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End-effector

For stroke rehabilitation 5 days a week in addition to conventional treatment methods robot-assisted gait training(end-effector type-Lokohelp) will be taken with 45 minutes a day for 3 days a week for 4 weeks.

Patients will be assessed with PASS, Rivermead mobility index, 10-meter walking test, 6-minute walking test, Barthel index, and FAC in terms of baseline and ending for posture, mobility, walking velocity, walking capacity, daily life activities and ambulance level.

Group Type ACTIVE_COMPARATOR

robot-assisted gait training

Intervention Type OTHER

Investigators will use robot-assisted gait training for rehabilitation of stroke

Exoskeleton

For stroke rehabilitation 5 days a week in addition to conventional treatment methods robot-assisted gait training (exoskeleton type-Robogait) will be taken with 45 minutes a day for 3 days a week for 4 weeks.

Patients will be assessed with PASS, Rivermead mobility index, 10-meter walking test, 6-minute walking test, Barthel index, and FAC in terms of baseline and ending for posture, mobility, walking velocity, walking capacity, daily life activities and ambulance level.

Group Type ACTIVE_COMPARATOR

robot-assisted gait training

Intervention Type OTHER

Investigators will use robot-assisted gait training for rehabilitation of stroke

conventional treatment

conventional treatment methods for stroke rehabilitation 5 days a week Patients will be assessed with PASS, Rivermead mobility index, 10-meter walking test, 6-minute walking test, Barthel index, and FAC in terms of baseline and ending for posture, mobility, walking velocity, walking capacity, daily life activities and ambulance level.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Investigators will use only conventional treatment without robot-assisted gait training

Interventions

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robot-assisted gait training

Investigators will use robot-assisted gait training for rehabilitation of stroke

Intervention Type OTHER

placebo

Investigators will use only conventional treatment without robot-assisted gait training

Intervention Type OTHER

Other Intervention Names

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conventional treatment

Eligibility Criteria

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Inclusion Criteria

* Rehabilitation need for stroke
* Patients under FAC stage 4
* No contraindications for robotic rehabilitation
* Subacute stroke

Exclusion Criteria

* The robot-orthosis does not fit the patient's body
* Inadequate body weight (obesity)
* Severe contractures
* Bone instability (nonstable spinal cord fracture and severe osteoporosis)
* Circulation problems
* Cardiac problems
* Open wounds on the lower extremities or in the body where they will come into contact with the orthosis
* Uncoordinated, psychotic or aggressive patients
* Serious cognitive disorders
* Patients with long-term infusion therapy
* Hip, knee, ankle arthrodesis
* Epilepsy
* Patients with disproportionate limb or vertebrae, such as bone cartilage dysplasia
* Those with severe vascular problems of the lower extremity
* Conditions requiring rest or immobilization, such as osteomyelitis and other inflammatory/infectious diseases
* Severe respiratory diseases
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erenköy Physical Therapy and Rehabilitation Hospital

OTHER

Sponsor Role lead

Responsible Party

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AYLİN SARI

Medical Doctor,

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aylin SARI

Role: STUDY_CHAIR

Dr.

Locations

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Erenkoy physical treatment and rehabilitation hospital

Istanbul, In the USA Or Canada, Please Select..., Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ErenkoyPTRH

Identifier Type: -

Identifier Source: org_study_id

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