The Effect of Robot-assisted Walking Training on Hemiplegic Individuals

NCT05492097 | Completed

• 1 other identifier: E-10840098-772.02-667
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the effects of robotic rehabilitation on balance, body control, mobility, spasticity, motor function and depression compared to traditional therapy in individuals with chronic stroke. Patients aged between 40-70 years, who applied to the Private Avrasya Hospital Physical Therapy and Rehabilitation Clinic, were diagnosed with hemiplegia based on an epicrisis medical board report, were included in the study on a voluntary basis, regardless of gender. After recording the demographic and clinical information of the participants, based on the physician's decision, they were included in 2 groups: conventional treatment combined with robotic rehabilitation (n=20) and conventional treatment only (n=20). While one of the groups received traditional treatment, the other group received robotic walking training in addition to conventional treatment. Traditional treatment includes strengthening, balance, range of motion exercises and gait training applied 3 days a week for 4 weeks. Robot-assisted walking training was planned for 20 minutes, 3 days a week. As assessment methods, number of steps, the 10m Walk Test, Brunnstrom motor staging, Functional Ambulation Classification, Fugl Meyer Rating Scale (lower extremity section), Modified Ashworth Scale, Beck Depression Scale, Tinetti Balance and Gait Test, Postural Assessment Scale in Stroke Patients and Stroke Impact Scale were used. Gender, age and duration of illness showed homogeneous distribution between the groups.

Conditions

Hemiplegia; Gait, Hemiplegic; Motor Function; Balance; Distorted

Outcome Measures

Primary Outcomes (10)

• The 10-meter walking test

  The 10-meter walking test will be performed in the 16-meter walking area without looking at the first and last 3 meters. The stopwatch will be started after the patient walks for the first 3 meters and the time will be stopped after the 10 meters are completed. The time to complete the 10 meters will be determined in seconds.

  0-4 weeks

• Number of Steps

  Calculation of the number of steps in one minute.

  0-4 weeks

• The Fugl Meyer Rating Scale

  The Fugl Meyer Rating Scale is a scale used to evaluate sensorimotor impairment in individuals with stroke. The maximum score is 226, which corresponds to full sensory-motor recovery. It is an ordinal scale with 3 points for each item. A given task is given 0 points if it cannot be done, 1 point if it is partially done, and 2 points if it is done completely. Reflex activity is measured using only 2 points, 0 points are given if there is no reflex, and 2 points are given if there is. In the study, the 34-point part of the scale for the lower extremity will used.

  0-4 weeks

• The Postural Rating Scale in Stroke Patients

  The Postural Rating Scale for Stroke Patients (PASS-Turk) will be used to assess trunk control. This scale helps to predict prognosis, shape treatment, and monitor time-dependent improvement. It is advantageous in that it is comprehensive, sensitive in evaluating changes in patients, and can be used even in patients with low physical capacity. The scale consists of 12 questions and each question is scored between 0-3 (0 = unable to do, 3 = able to do without assistance).

  0-4 weeks

• Tineti Balance and Gait Assessment

  The scale consists of 2 subtests: the first 9 questions are about balance and the next 7 questions are about walking. In 16 questions, the movements during ADL are questioned. If the movement is done correctly, 2 points are given, if the movement is made with adaptations, 1 point is given, if it cannot be done, 0 points are given. If the total score is 18 and below, the risk of falling is high, if it is 19-24, the risk of falling is moderate, and if it is 24 and above, the risk of falling is high.

  0-4 weeks

• The Stroke Impact Scale

  The Stroke Impact Scale will be used as a stroke-specific health status measure in the assessment of quality of life. It consists of a total of 59 items and 8 subsections: strength, hand function, activities of daily living, mobility, communication, emotion, memory and thinking, participation. If the patient cannot complete the item, he will be asked to give 1 point, if he has no difficulty in completing it, he will be asked to give 5 points. At the end of the scale, the visual analog scale (0: No recovery, 100: Complete recovery) will evaluate the perception of general recovery after stroke.

  0-4 weeks

• Brunnstrom motor staging

  Brunnstrom motor staging is a test that measures motor progress in parts of the central nervous system that regulate motor performance in patients with hemiplegia. The degree of recovery of the central nervous system is evaluated by enabling the patient to perform selected motor actions that require progressively better neuromuscular control. There are 6 stages for the lower extremity

  0-4 weeks

• Functional Ambulation Scale

  The amount of physical support that patients need during walking will be determined by the Functional Ambulation Scale. Evaluation is made out of 6 points between 0-5 (0=Cannot ambulatory alone, 5=Can walk independently on all kinds of surfaces).

  0-4 weeks

• The Modified Ashworth Scale

  The Modified Ashworth Scale is the most commonly used assessment method for spasticity in the international arena (10). The patient is examined in a supine and relaxed position. The joint is moved passively, repetitively and rapidly, and is scored between 0 and 4 according to the resistance of the joint to movement (0 = no increase in tone, 4 = the affected extremity is rigid in flexion and extension).

  0-4 weeks

• Beck Depression Scale

  Emotional symptoms such as hopelessness and guilt and physical symptoms such as weight loss, fatigue and insomnia are also examined in the questions in the scale. There are 21 questions, points are given between 0-3. According to the total score, it is evaluated as follows: 0 to 9 points = minimal depressive symptoms, 10 to 16 points = mild depressive symptoms, 17 to 29 points = moderate depressive symptoms, 30 to 63 points = severe depressive symptoms .

  0-4 weeks

Study Arms (2)

Exercise Group

EXPERIMENTAL

For the patients in this group, 3 days a week for 4 weeks; various exercises and walking training will be given in sitting, crawling, kneeling, half-kneeling and standing positions and 20 minutes NMES will be applied.

Behavioral: Exercise Therapy

Exercise and Robotic Group

EXPERIMENTAL

In addition to the exercise group treatment, patients will receive gait training for 4 weeks, 3 sessions a week, with the last effector fixed robot Lokohelp.

Behavioral: Exercise Therapy and Robotic Walking Training

Interventions

Exercise Therapy BEHAVIORAL

Traditional exercise therapy and NMES

Exercise Group

Exercise Therapy and Robotic Walking Training BEHAVIORAL

Traditional exercise therapy and Robotic Walking Training

Exercise and Robotic Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having had a stroke once and associated hemiplegia,
• At least 1 year has passed since the stroke,
• Stage 3 and above in terms of lower extremity recovery level according to the Brunnstrom motor staging scale,
• Level 2 and above according to the Functional Ambulation Classification

You may not qualify if:

• Concomitant peripheral nerve lesion or lower motor neuron disease;
• Presence of other neurological disorders such as ataxia, dyskinesia, dystonia;
• Any circulatory disorder
• Presence of advanced osteoporosis, arrhythmia, or serious heart condition;
• Advanced spasticity, peripheral lesion, pressure sore, advanced muscle atrophy, obesity, skin irritation, presence of cardiac pacemaker;
• Surgery or botulinum toxin administration in the last 6 months

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemiplegia; Gait Disorders, Neurologic

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Gülay Aras Bayram, PhD

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Controlled study

Study Record Dates

• First Submitted: August 4, 2022
• First Posted: August 8, 2022
• Study Start: February 14, 2022
• Primary Completion: December 12, 2022
• Study Completion: December 21, 2022
• Last Updated: December 22, 2022

Record last verified: 2022-12

Locations

TU (1)