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Completed

NCT Number: NCT05492097

The Effect of Robot-assisted Walking Training on Hemiplegic Individuals

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.

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Key information

Conditions

Hemiplegia Balance; Distorted Gait Disorders, Neurologic Gait, Hemiplegic Motor Function Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

About this study

More than 80% of stroke survivors have impaired walking ability, but most regain their ability to walk. While 40% of them need help while walking, 60% of the group do not have the ability to move independently outside the home. Balance disorder is the most common problem after stroke. Decreased muscle strength and joint range of motion and impaired coordination and sensory organization mechanism prevent balance. 80% of individuals who have had a stroke for the first time have balance disorder in the subacute phase. As a result of restricted balance, postural control deteriorates, the risk of falling increases and mobility decreases.

Interventions to improve gait function should be intense, repetitive, and task-oriented. Intensive efforts of more than one physiotherapist are required in patients who do not have independent gait. Robot assisted walking devices; provides high-intensity, repetitive, task-specific therapy. It both reduces the workload of physiotherapists and improves gait quality, functional results (walking speed and capacity) and motor performance with multi-sensory stimulation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Exercise Therapy

Behavioral

Traditional exercise therapy and NMES

Exercise Therapy and Robotic Walking Training

Behavioral

Traditional exercise therapy and Robotic Walking Training

Primary outcomes

  1. The 10-meter walking test

    Time frame: 0-4 weeks

    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.

  2. Number of Steps

    Time frame: 0-4 weeks

    Calculation of the number of steps in one minute.

  3. The Fugl Meyer Rating Scale

    Time frame: 0-4 weeks

    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.

  4. The Postural Rating Scale in Stroke Patients

    Time frame: 0-4 weeks

    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).

  5. Tineti Balance and Gait Assessment

    Time frame: 0-4 weeks

    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.

  6. The Stroke Impact Scale

    Time frame: 0-4 weeks

    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.

  7. Brunnstrom motor staging

    Time frame: 0-4 weeks

    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

  8. Functional Ambulation Scale

    Time frame: 0-4 weeks

    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).

  9. The Modified Ashworth Scale

    Time frame: 0-4 weeks

    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).

  10. Beck Depression Scale

    Time frame: 0-4 weeks

    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 .

Sponsors and collaborators

Lead sponsor

Medipol University

Other

Registry information

Official study title

The Effect of Robot-assisted Walking Training on Balance, Trunk Control, Mobility, Spasticity and Motor Function in Hemiplegic Individuals

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 8, 2022
Registry last updated
Dec 22, 2022

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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