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Completed

NCT Number: NCT03565185

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

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

Completed

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erenkoy physical treatment and rehabilitation hospital

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

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

robot-assisted gait training

Other

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

Placebo

Other

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

Other names: conventional treatment

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Erenköy Physical Therapy and Rehabilitation Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 21, 2018
Registry last updated
May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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