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

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ClinicalTrials.gov Identifier: NCT03565185
Recruitment Status : Completed
First Posted : June 21, 2018
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
AYLİN SARI, Erenköy Physical Therapy and Rehabilitation Hospital

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

Condition or disease Intervention/treatment Phase
Stroke Other: robot-assisted gait training Other: placebo Not Applicable

Detailed Description:
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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison Of An Exoskeleton Device With An End-Effector Device In Robotic Gait Assesment Of Stroke
Actual Study Start Date : June 30, 2018
Actual Primary Completion Date : March 30, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.

 Other: robot-assisted gait training
Investigators will use robot-assisted gait training for rehabilitation of stroke
Active Comparator: 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.

 Other: robot-assisted gait training
Investigators will use robot-assisted gait training for rehabilitation of stroke
Placebo Comparator: 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.
 Other: placebo
Investigators will use only conventional treatment without robot-assisted gait training
Other Name: conventional treatment


Outcome Measures
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Primary Outcome Measures :
  1. 6 minute walk test [ Time Frame: 4 weeks ]
    6 minute walk test for walking speed

  2. 10 meter walking test [ Time Frame: 4 weeks ]
    10 meter walking test for walking

  3. Postural Assessment Scale for Stroke(PASS) [ Time Frame: 4 weeks ]
    Postural Assessment Scale for Stroke(PASS) will be used


Secondary Outcome Measures :
  1. FAC(Functional Ambulation Classification) [ Time Frame: 4 weeks ]
    FAC will be used for ambulation

  2. Barthel Index [ Time Frame: 4 weeks ]
    Barthel Index will be used for daily living activities


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03565185


Locations
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Turkey
Erenkoy physical treatment and rehabilitation hospital
Istanbul, In The USA Or Canada, Please Select..., Turkey, 34400
Sponsors and Collaborators
Erenköy Physical Therapy and Rehabilitation Hospital
Investigators
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Study Chair: Aylin SARI Dr.
More Information
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Responsible Party: AYLİN SARI, Medical Doctor,, Erenköy Physical Therapy and Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT03565185    
Other Study ID Numbers: ErenkoyPTRH
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases