Clinical trial NCT05447754: Comparison of the Effects of Robotic Rehabilitation Versus Traditional Balance Training on Balance and Fear of Falling in Stroke Patients
Official title: Comparison of the Effects of Robotic Rehabilitation Versus Traditional Balance Training on Balance and Fear of Falling in Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Stroke Rehabilitation
Robotic Exoskeleton
Keywords: Stroke
Stroke Rehabilitation
Robot assisted gait training
Balance training
Fear of falling
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the literature, it has been observed that traditional balance training (TBT) and robot-assisted walking training (RAGT) in stroke patients stimulate the balance mechanism by supporting the spinal muscles symmetrically and functionally. However, it is seen that there is no clear protocol for RAGT in the chronic period. Combined RAGT and TBT approaches over ten weeks have been shown to be more effective than TBT alone for the acute and subacute period. However, there is no definite expression for chronic period effects. No study was found in the literature in which an objective measuring device was used for balance assessment of patients receiving TBT and RAGT. If changes are detected between the two treatment groups in balance education in stroke patients as a result of objective evaluation, our study will lead to the necessity of including these changes in the treatment. Considering the effect of balance on activities of daily living, we believe that objective evaluation of the changes in balance after TBT and RAGT in stroke patients and shaping the treatment according to the evaluation results will contribute to the literature.


Eligibility criteria: Inclusion Criteria:

* Being 18 years or older
* Volunteering to participate in the study
* Having been diagnosed with stroke (at least 3 months)
* Age range 18 ≥ or 75 \<
* Being able to walk independently (Functional Ambulation Scale\> 3)
* Modified Ashworth Scale ≤ 2 spasticity value

Exclusion Criteria:

* Being under the age of 18
* Having severe visual and cognitive impairment
* Having severe cardiovascular disease
* Having experienced musculoskeletal injuries (osteoarthritis, contracture, osteoporosis, etc. in the joints of the lower extremities) or any skin problem (such as pressure sores)
* Being involved in a robotic rehabilitation program before

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 5 weeks
measure: EncephaLog by Montfort® App
timeFrame: 5 weeks
measure: International Fall Efficiency Scale (FES-I)
timeFrame: 5 weeks
measure: Timed Get Up and Go Test
timeFrame: 5 weeks
Secondary outcomes:
measure: Foot Posture Index
timeFrame: 5 weeks
measure: Functional Ambulation Scale
timeFrame: 5 weeks
measure: Modified Ashworth Scale
timeFrame: 5 weeks
measure: Fugl-Meyer Test- Lower Extremity
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Rüstem Mustafaoğlu, PhD
role: STUDY_CHAIR
References: