Clinical trial NCT05492097: The Effect of Robot-assisted Walking Training on Hemiplegic Individuals
Official title: The Effect of Robot-assisted Walking Training on Balance, Trunk Control, Mobility, Spasticity and Motor Function in Hemiplegic Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia
Gait, Hemiplegic
Motor Function
Balance; Distorted
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Controlled study
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The 10-meter walking test
timeFrame: 0-4 weeks
measure: Number of Steps
timeFrame: 0-4 weeks
measure: The Fugl Meyer Rating Scale
timeFrame: 0-4 weeks
measure: The Postural Rating Scale in Stroke Patients
timeFrame: 0-4 weeks
measure: Tineti Balance and Gait Assessment
timeFrame: 0-4 weeks
measure: The Stroke Impact Scale
timeFrame: 0-4 weeks
measure: Brunnstrom motor staging
timeFrame: 0-4 weeks
measure: Functional Ambulation Scale
timeFrame: 0-4 weeks
measure: The Modified Ashworth Scale
timeFrame: 0-4 weeks
measure: Beck Depression Scale
timeFrame: 0-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
Study officials:
affiliation: Medipol University
name: Gülay Aras Bayram, PhD
role: PRINCIPAL_INVESTIGATOR
References: