NCT03565185

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 21, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

June 30, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

1.8 years

First QC Date

May 21, 2018

Last Update Submit

May 11, 2020

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • FAC(Functional Ambulation Classification)

    4 weeks

  • Barthel Index

    4 weeks

Study Arms (3)

End-effector

ACTIVE COMPARATOR

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

Exoskeleton

ACTIVE COMPARATOR

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

conventional treatment

PLACEBO COMPARATOR

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

robot-assisted gait trainingOTHER

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

End-effectorExoskeleton
placeboOTHER

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

Also known as: conventional treatment
conventional treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erenkoy physical treatment and rehabilitation hospital

Istanbul, In the USA Or Canada, Please Select..., 34400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Aylin SARI

    Dr.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor,

Study Record Dates

First Submitted

May 21, 2018

First Posted

June 21, 2018

Study Start

June 30, 2018

Primary Completion

March 30, 2020

Study Completion

April 1, 2020

Last Updated

May 13, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)