CClinicalTrials.gg
CompletedNCT03565185Updated May 13, 2020

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

An interventional study of robot-assisted gait training and placebo in Stroke, sponsored by Erenköy Physical Therapy and Rehabilitation Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-13.

Sponsored by Erenköy Physical Therapy and Rehabilitation Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Stroke

Browse trials for

03

In context

Stroke

7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.

This study's enrollment of 64 is above the median of 50 across 5,370 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Erenköy Physical Therapy and Rehabilitation Hospital is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
64 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • Otherrobot-assisted gait training

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

  • Otherplacebo

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

    Also known as: conventional treatment

06

What researchers measure

Primary outcomes

  1. 6 minute walk test

    6 minute walk test for walking speed

    Time frame: 4 weeks

  2. 10 meter walking test

    10 meter walking test for walking

    Time frame: 4 weeks

  3. Postural Assessment Scale for Stroke(PASS)

    Postural Assessment Scale for Stroke(PASS) will be used

    Time frame: 4 weeks

Secondary outcomes

  1. FAC(Functional Ambulation Classification)

    FAC will be used for ambulation

    Time frame: 4 weeks

  2. Barthel Index

    Barthel Index will be used for daily living activities

    Time frame: 4 weeks

07

Study locations

1 site
  • Erenkoy physical treatment and rehabilitation hospital
    Istanbul, In The USA Or Canada, Please Select... 34400, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03565185
Lead sponsor
Erenköy Physical Therapy and Rehabilitation Hospital
Responsible party
AYLİN SARI (Medical Doctor,, Erenköy Physical Therapy and Rehabilitation Hospital) — Principal investigator
First posted
Jun 21, 2018
Start date
Jun 30, 2018
Primary completion
Mar 30, 2020
Completion
Apr 1, 2020
Last update
May 13, 2020

Study contacts

Aylin SARI
study chair · Dr.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion