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

Comparison Of An Exoskeleton Device With An End-Effector Device In Robotic Gait Assesment Of Stroke

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

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: robot-assisted gait training; Other: placebo

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • In The USA Or Canada, Please Select...
    • Istanbul, In The USA Or Canada, Please Select..., Turkey, 34400
      • Erenkoy physical treatment and rehabilitation hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minute walk test	6 minute walk test for walking speed	4 weeks
10 meter walking test	10 meter walking test for walking	4 weeks
Postural Assessment Scale for Stroke(PASS)	Postural Assessment Scale for Stroke(PASS) will be used	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FAC(Functional Ambulation Classification)	FAC will be used for ambulation	4 weeks
Barthel Index	Barthel Index will be used for daily living activities	4 weeks

Collaborators and Investigators

• Sponsor: Erenköy Physical Therapy and Rehabilitation Hospital
• Investigators: Study Chair: Aylin SARI, Dr.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2018
• Primary Completion (ACTUAL): March 30, 2020
• Study Completion (ACTUAL): April 1, 2020

Study Registration Dates

• First Submitted: May 21, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (ACTUAL): June 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: ErenkoyPTRH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No