Comparison of an Exoskeleten With an End-effector for Assisted Gait Training in Spinal Cord Injury

NCT ID: NCT03544398

Last Updated: 2020-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-06-30

Brief Summary

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Aim is to compare exoskeleton assisted gait training with end-effector assisted gait training in Spinal Cord Rehabilitation

Detailed Description

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It was planned to evaluate patients aged between 18 and 80 years who will admit to the robotic rehabilitation program due to spinal cord injury. Patients will divide into three groups as Exoskeleton, End-effector and conventional therapy. Exoskeleton and End-effector group will receive robotic therapy 4 days a week besides conventional treatment for 6 weeks. All groups will be evaluated at the start and end of the treatment.

Conditions

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Spinal Cord Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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exoskeleton

We will use exoskeleton type robot assisted gait training for spinal cord injury rehabilitation

Group Type ACTIVE_COMPARATOR

robot assisted gait training

Intervention Type OTHER

we use two types of robot assisted gait training and we will compare two groups.

end-effector

We will use end-effector type robot assisted gait training for spinal cord injury rehabilitation

Group Type ACTIVE_COMPARATOR

robot assisted gait training

Intervention Type OTHER

we use two types of robot assisted gait training and we will compare two groups.

conventional physiotherapy

Group Type PLACEBO_COMPARATOR

robot assisted gait training

Intervention Type OTHER

we use two types of robot assisted gait training and we will compare two groups.

Interventions

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robot assisted gait training

we use two types of robot assisted gait training and we will compare two groups.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Clinical diagnosis of spinal cord injury Applying to the hospital for a rehabilitation program

Exclusion Criteria

Inadequate body weight (obesity) Severe contractures Bone instability ( nonstable spinal cord fracture, and severe osteoporosis) Circulation problems Cardiac nonconformity 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 Long-term infusion therapy Hip, knee, ankle arthrodesis Epilepsy Disproportionate limb or vertebrae, such as bone cartilage dysplasia
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erenköy Physical Therapy and Rehabilitation Hospital

OTHER

Sponsor Role lead

Responsible Party

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AYLİN SARI

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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unsal SARI

Role: STUDY_CHAIR

Dr.

Locations

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Aylin Sari

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

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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AYLİN SARI

Role: CONTACT

05058396368

Facility Contacts

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AYLİN SARI

Role: primary

05058396368

Other Identifiers

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Erenkoy

Identifier Type: -

Identifier Source: org_study_id

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