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The effect of HExA exoskeleton robot on stroke patients

The effect of using HExA exoskeleton robot in comparison with conventional physiotherapy on disability, walking quality and quality of life of stroke patients with one-sided involvement: A randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210730052024N1
Enrollment
20
Registered
2022-01-28
Start date
2022-02-09
Completion date
Unknown
Last updated
2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spastic hemiplegia. Spastic hemiplegia

Interventions

Intervention 1: Intervention group: Therapeutic sessions in both groups will be four sessions per week, including four weeks. Each 60-minute treatment session includes 30 minutes of electrotherapy usi

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Ischemic or hemorrhagic stroke patients in subacute phase(less than 3 month) Involvement of one side of the body(hemiplegia) Age 18-85 years Patients have the ability to walk without the help of others (with or without a cane, etc.) (low to moderate disorder) The patient should be able to understand the therapist's instructions, which will be diagnosed using the Mini-mental state examination (MMSE) (MMSE score=24)

Exclusion criteria

Exclusion criteria: The patient be in flaccid phase that can not walk even with the help of therapist or use of assistive device such as cane Stroke due to tumor or infection Significant musculoskeletal or neurological impairment Uncontrolled cardiovascular or respiratory impairments Involvement of two sides of the body or quadriplegia Pregnancy A patient with Pusher syndrome will not be included in the study The patient will not be able to walk before the stroke will not be included in the study If the patient can not safely use the robot due to severe spasticity (Modified ashworth scale above 3) will not be included in the study If the patient's size does not match the robot, he will not be included in the study; The patient's pelvic circumference from the anterior superior iliac spine should be between 37 and 42 cm and also the distance between the large trochanter and the knee should be at least 25 cm. Patient dissatisfaction to continue attending the study Emergence of any of the factors of non-entry during the implementation of the plan in the patient

Design outcomes

Primary

MeasureTime frame
Walking quality in the six-minute walk test. Timepoint: Measurement of distance traveled in six minutes, at the beginning of the intervention (before the intervention) and at the end of twelve sessions of treatment. Method of measurement: Six minute walk test: This test is used to assess aerobic capacity and endurance. The interval of 6 minutes is used as a result to compare changes in performance capacity. This test can be used in people of different ages and with a wide range of diagnoses. This test was initially designed to help assess patients with cardiopulmonary problems and has gradually been used in many other conditions. This test has acceptable validity and repeatability with ICC = 0.99.

Secondary

MeasureTime frame
The degree of disability with functional gait assessment. Timepoint: Functional gait assessment test score at the beginning of the study before the intervention and at the end of twelve sessions of treatment. Method of measurement: Functional gait assessment test: It is one of the most important and valid tools for measuring the ability to walk in the elderly. The purpose of the designers of this scale was to standardize the functional abilities of walking over time and to evaluate the response of clients and patients to measures, therapeutic interventions and rehabilitation with the aim of improving the walking pattern of the elderly. This scale can also be used to measure the gait of middle-aged people with various diseases. This test is a 10-item tool that gives each question a score from 0 to 3 and has a total of 30 points. Persian translation of this tool from the structure It has an acceptable factor and credibility and is a suitable tool for measuring gait and balance.;Level of disability at the berg balance scale. Timepoint: Berg balance scale test score at the beginning of the study before the intervention and at the end of twelve sessions of treatment. Method of measurement: The Berg Balance Test is a performance-based test to assess functional balance. The test is named after Katherine Berg, one of the test developers. This test takes about 10 to 20 minutes. This test consists of 14 balance sections. The minimum score for each ward is zero and the maximum score is 4. If the patient's total score is less than or equal to 20, the patient will need a wheelchair. If the patient's total score is greater than 20 and less than or equal to 40, the patient will need assistance in walking. Patients with a score greater than 40 can walk independently. Various researchers have reported acceptable reproducibility and validity for this test. The Persian version of the test has acceptable reproducibility and validity in elderly populations with ICC = 0.93.;Walking quali

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Ali Hoseini

Mashhad University of Medical Sciences

physahm@gmail.com+98 51 3882 8299

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 6, 2026