To Investigate the Effects of Robotic-assisted Gait Training in Stroke Patients

NCT ID: NCT04033185

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2020-01-20

Brief Summary

The primary aim of the study was to investigate the effects of robot-assisted gait training and virtual reality on knee joint position sense in patients with chronic stroke. The secondary objective is to examine the effectiveness of these applications on functional gait and balance.

Detailed Description

Despite widespread prevention programs worldwide and advances in acute and subacute management and treatment protocols, stroke remains one of the most common causes of adult disability, representing a serious global health problem. Sensory motor dysfunction, proprioception deficits and hypertonus may develop in stroke patients depending on the location and severity of the brain damaged areas. Virtual reality application, which has been widely used in recent years, is a three-dimensional, computer-generated technology that gives the patient a sense of reality and allows the patient to interact with it. Virtual reality application can be used as a suitable method for proprioceptive rehabilitation due to its ability to manipulate visual feedback of virtual objects. In recent years, another technological method that has been used in the field of neurorehabilitation is robotic rehabilitation. Robot-assisted gait training, which requires repetitive tasks, can enhance neuroplasticity and motor learning, which focuses on the rearrangement of brain tissue. Both technology-based rehabilitation approaches have been shown to be particularly effective in improving the sense of position in the upper extremity. However, studies investigating the effects of these two applications on lower extremity position sensation seem to be insufficient. We think that both methods will be effective in improving the sense of position.

Conditions

Stroke; Cerebrovascular Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study group

virtual reality, robot-assisted gait training, conventional treatment

Group Type: ACTIVE_COMPARATOR

virtual reality, robot assisted gait training

Intervention Type: OTHER

study group: 15 sessions virtual reality, robot assisted gait training

conventional treatment

Intervention Type: OTHER

study group: 15 sessions conventional treatment control group: 30 sessions conventional treatment

control group

conventional treatment

Group Type: OTHER

conventional treatment

Intervention Type: OTHER

study group: 15 sessions conventional treatment control group: 30 sessions conventional treatment

Interventions

virtual reality, robot assisted gait training

study group: 15 sessions virtual reality, robot assisted gait training

Intervention Type: OTHER

conventional treatment

study group: 15 sessions conventional treatment control group: 30 sessions conventional treatment

Intervention Type: OTHER

Other Intervention Names

conventional treatment

Eligibility Criteria

Inclusion Criteria

• Having been diagnosed with stroke by specialist physician,
• 6 months after stroke diagnosis,
• Hemiplegia or hemiparesis due to stroke for the first time,
• Being over 18,
• Being able to walk with auxiliary device or independently,
• Mini Mental test score> 24,
• Functional Ambulation Classification FAC ≥ 2,
• Agree to participate in the study.

Exclusion Criteria

• Acute internal discomfort,
• Botulinum toxin administration during 6 months before treatment or during treatment,
• Presence of a history of previous stroke,
• Having influence on both sides,
• Neglect syndrome,
• Presence of severe spasticity (Modified Ashwort Scale> 2),
• Patients weighing more than 100 kg,
• Patients with femoral lengths greater than 50cm

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gazi University

OTHER

Sponsor Role: lead

Responsible Party

FATOS KIRTEKE

principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arzu Güçlü Gündüz, prof.

Role: STUDY_DIRECTOR

Gazi University

Locations

Kozaklı Physical Therapy and Rehabilitation Hospital

Nevşehir, Kozakli, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

gazi-ftr-neurological-rehab

Identifier Type: -

Identifier Source: org_study_id