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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
robot-assisted gait training
placebo
Sponsored by
Erenköy Physical Therapy and Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erenkoy physical treatment and rehabilitation hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

End-effector

Exoskeleton

conventional treatment

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

6 minute walk test
6 minute walk test for walking speed
10 meter walking test
10 meter walking test for walking
Postural Assessment Scale for Stroke(PASS)
Postural Assessment Scale for Stroke(PASS) will be used

Secondary Outcome Measures

FAC(Functional Ambulation Classification)
FAC will be used for ambulation
Barthel Index
Barthel Index will be used for daily living activities

Full Information

First Posted
May 21, 2018
Last Updated
May 11, 2020
Sponsor
Erenköy Physical Therapy and Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03565185
Brief Title
Comparison Of Two Different Type Robot Assisted Gait Training In Rehabilitation Of Stroke
Official Title
Comparison Of An Exoskeleton Device With An End-Effector Device In Robotic Gait Assesment Of Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
June 30, 2018 (Actual)
Primary Completion Date
March 30, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erenköy Physical Therapy and Rehabilitation Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
End-effector
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Exoskeleton
Arm Type
Active Comparator
Arm Description
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.
Arm Title
conventional treatment
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
robot-assisted gait training
Intervention Description
Investigators will use robot-assisted gait training for rehabilitation of stroke
Intervention Type
Other
Intervention Name(s)
placebo
Other Intervention Name(s)
conventional treatment
Intervention Description
Investigators will use only conventional treatment without robot-assisted gait training
Primary Outcome Measure Information:
Title
6 minute walk test
Description
6 minute walk test for walking speed
Time Frame
4 weeks
Title
10 meter walking test
Description
10 meter walking test for walking
Time Frame
4 weeks
Title
Postural Assessment Scale for Stroke(PASS)
Description
Postural Assessment Scale for Stroke(PASS) will be used
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
FAC(Functional Ambulation Classification)
Description
FAC will be used for ambulation
Time Frame
4 weeks
Title
Barthel Index
Description
Barthel Index will be used for daily living activities
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aylin SARI
Organizational Affiliation
Dr.
Official's Role
Study Chair
Facility Information:
Facility Name
Erenkoy physical treatment and rehabilitation hospital
City
Istanbul
State/Province
In The USA Or Canada, Please Select...
ZIP/Postal Code
34400
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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