The Effect of Robot-assisted Walking Training on Hemiplegic Individuals

NCT ID: NCT05492097

Last Updated: 2022-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-14
• Study Completion Date: 2022-12-21

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.

Detailed Description

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.

Conditions

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

Study Design

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

Study Groups

Exercise Group

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.

Group Type: EXPERIMENTAL

Exercise Therapy

Intervention Type: BEHAVIORAL

Traditional exercise therapy and NMES

Exercise and Robotic Group

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.

Group Type: EXPERIMENTAL

Exercise Therapy and Robotic Walking Training

Intervention Type: BEHAVIORAL

Traditional exercise therapy and Robotic Walking Training

Interventions

Exercise Therapy

Traditional exercise therapy and NMES

Intervention Type: BEHAVIORAL

Exercise Therapy and Robotic Walking Training

Traditional exercise therapy and Robotic Walking Training

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medipol University

OTHER

Sponsor Role: lead

Responsible Party

Gülay Aras

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gülay Aras Bayram, PhD

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

Istanbul Medipol University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

E-10840098-772.02-667

Identifier Type: -

Identifier Source: org_study_id