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

NCT04033185 | Completed DMC

• 1 other identifier: gazi-ftr-neurological-rehab
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cerebrovascular Disorders

Keywords

joint position sense; stroke; virtual reality; robot assisted gait training

Outcome Measures

Primary Outcomes (9)

• functional ambulation classification (FAC)

  FAC is used to assess ambulation ability. It is a valid and reliable scale that evaluates the physical support needed during gait from 6 to 0 points. A high score indicates a good gait and a decrease in score indicates a poor gait.

  Before treatment

• Activity-Specific Balance Safety Scale

  The level of confidence that the patient feels in daily life activities that require balance skills will be assessed with the Activity-Specific Balance Safety Scale. In this scale, individuals are asked to rate the safety feeling they feel between 0% and 100% when performing 16 activities that require the specified balance skill. A score of 100% indicates that the activity will be performed completely safely, and a score of 0% indicates that the activity is not safe at all.

  change from baseline score at the end of 5 weeks

• Modified Ashworth Scale

  It is a reliable, valid scale commonly used in the assessment of muscle tone. Resistance to passive motion is graded between 0 and 4. A score of 0 defines normal in muscle tone. the score of 1 defines minimal resistance is felt at the end of the range of motion, the score of 1+ defines resistance is felt in less than half of the range of motion, the score of 2 defines resistance is felt in most of the range of motion, but the affected part is easily moved, the score of 3 defines the resistance along the range of motion of the joint is greater and passive movement is difficult, the score of 4 defines the joint movement of the points is restricted and movement is not revealed.

  Before treatment

• Modified Rankin Scale

  Modified Rankin Scale will be used to determine the disability level of stroke individuals. The Modified Rankin Scale is a widely used, reliable scale to assess functional status after stroke. In this scale, disability is defined at 7 levels. While 6 points are defined as death, 0 points define completely normal functional status. 0 points indicate no symptoms, 1 point indicates that there is no disability despite symptoms, 2 points indicate mild disability, 3 points moderate disability; 4 points moderate-severe disability; 5 points represent severe disability and 6 points represent death.

  change from baseline score at the end of 5 weeks

• Stroke Rehabilitation Movement Assessment Scale- STREAM

  STREAM, which is widely used in post-stroke motor evaluation, is a valid and reliable scale. STREAM consists of 2 sections and a total of 30 tests evaluating the functional movements and basic mobility activities of the upper and lower extremities. Limb movements are evaluated with 2 points and mobility activities with 3 points. The highest score is 70. A high score indicates that motor impairment is low, and a decrease in score indicates an increase in motor impairment.

  change from baseline score at the end of 5 weeks

• Time up and go test

  It is a test where balance and functional mobility are evaluated together.

  change from baseline time at the end of 5 weeks

• Mobile Phone-Based Joint Angle Measurement

  DrGoniometer is an iPhone based joint goniometer application. With the DrGoniometer, the measurement is achieved by positioning a virtual goniometer that appears on the smartphone screen on a photo from the smartphone camera. The clinician takes a photograph of the extremity, records it, measures the joint angle and observes the value. Approximation of the difference between the target angle and the angle applied by the patient represents a good sense of joint position.

  change from baseline angle at the end of 5 weeks

• Berg Balance Scale

  It will be used to evaluate the functional balance. Berg balance scale includes 14 tests, which are graded between 0 and 4 by observing the patient's performance. higher values represent a better equilibrium state. A score of 0-20 indicates an imbalance, a score of 21-40 indicates an acceptable balance, a score of 41-56 indicates a good balance.

  change from baseline score at the end of 5 weeks

• goniometric measurement

  Proprioception can be defined as the perception of the position and of the movement of various body parts in space. Its role is essential in sensorimotor control for movement acuity, joint stability, coordination, and balance. Its clinical evaluation is commonly based on the assessment of the joint position sense (JPS). Both ROM and JPS measurements require estimating angles through goniometer, scoliometer, laser-pointer, and bubble or digital inclinometer. The goniometer will be used to assess the sense of joint position. Approximation of the difference between the target angle and the angle applied by the patient represents a good sense of joint position.

  change from baseline angle at the end of 5 weeks

Study Arms (2)

study group

ACTIVE COMPARATOR

virtual reality, robot-assisted gait training, conventional treatment

Other: virtual reality, robot assisted gait training; Other: conventional treatment

control group

OTHER

conventional treatment

Other: conventional treatment

Interventions

virtual reality, robot assisted gait training OTHER

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

Also known as: conventional treatment

study group

conventional treatment OTHER

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

control group; study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having been diagnosed with stroke by specialist physician,
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

Kozaklı Physical Therapy and Rehabilitation Hospital

Nevşehir, Kozakli, 50600, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Arzu Güçlü Gündüz, prof.

  Gazi University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal Investigator

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 25, 2019
• Study Start: October 15, 2019
• Primary Completion: December 5, 2019
• Study Completion: January 20, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

TU (1)