Clinical trial NCT04756570: The Effect of Robot-Assisted Gait Training in Stroke Patients
Official title: The Effect of Robot-Assisted Gait Training Dose on Walking, Functional Recovery and Quality of Life in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Rehabilitation
Robotic
Stroke
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups with one control group
Primary purpose: TREATMENT

Brief summary: Stroke has been defined by the World Health Organization as a condition with rapid onset and vascular origin, leading to a focal or global deterioration in brain functions lasting 1 day or longer. Stroke is an important health problem affecting a large part of the society with its high frequency and mortality. Post-stroke disability reduces the patient's quality of life and causes socioeconomic and social problems. Post-stroke hemiplegia often causes a decrease in the ambulatory ability of the patient. As a result, the patient's independence to move inside and outside the home is negatively affected. Gait is one of the most affected sensorimotor functions in stroke patients. Although the majority of patients strive to walk independently, they cannot reach a level of independent walking sufficient to perform activities of daily living (ADL). Current studies emphasize that the intensive early rehabilitation program is effective in treating patients with gait and movement disorders. Rehabilitation programs with a multidisciplinary approach are the most effective options that can be applied to increase a patient's functional status and post-stroke independence. Robotic-assisted walking devices are one of the current and effective methods used to regain ambulation.

Detailed description: Robotic-assisted walking devices are used in the treatment of many neurological diseases such as spinal cord trauma, multiple sclerosis, post-stroke hemiplegia. In treatments applied with robotic walking devices, since accurate and equal weight transfer is provided in both lower extremities, sensorimotor learning of the patient is also supported. Thanks to the intense and repetitive simulation provided in every phase of the walk and the proprioceptive inputs taken, reorganization occurs in the cortical and sub-cortical regions. With the continuous facilitation of the walking cycle, neural transmission is regenerated or existing communication is strengthened between the motor areas of the brain and sensory pathways. The advantages of robotic systems can be listed as enabling longer and more intense treatments, ensuring that the patient feels better cognitively, adapting to exercise better, providing the opportunity to check the patient's condition objectively by monitoring and recording the patient's condition functionally. A recent systematic review showed that individuals with stroke who received robotic gait training combine with physiotherapy were more likely to achieve independent walking than those who received gait training without robotic gait training. Different studies on the effectiveness of robotic rehabilitation have reported that robot-assisted gait training should be applied together with a physiotherapy program. However, there is no clear information on the optimal dosage of Robot-Assisted Gait Training (RAGT) to achieve clinically meaningful functional recovery after a central nervous system injury. This study aims to investigate the effect of RAGT dosage on Functional Recovery and Quality of Life in patients with stroke.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with stroke
* Willing to participate
* Modified Ashworth Scale Score lower than "3"
* Able to walk 10 meter independently

Exclusion Criteria:

* Secondary neurological diseases
* Cognitive problems

Primary outcomes:
measure: Berg Balance Scale
timeFrame: Six weeks
Secondary outcomes:
measure: The Barthel Index
timeFrame: Six weeks
measure: Stroke-Specific Quality of Life Scale
timeFrame: Six weeks
measure: 6-min walk test
timeFrame: Six weeks
measure: Modified Rankin Scale
timeFrame: Six weeks
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Abant Izzet Baysal University
state: Merkez
Study officials:
affiliation: Bolu Abant Izzet Baylsa University
name: Mustafa Fatih Yaşar, MD
role: PRINCIPAL_INVESTIGATOR
References: