Clinical trial NCT06938477: Thera-Trainer Exercise Effects on Motor and Cognitive Outcomes in Stroke: RCT
Official title: EFFECTS OF THERA-TRAINER BASED EXERCISES ON MOTOR AND COGNITIVE PERFORMANCE AMONG HEMİPARATİC STROKE PATIENTS. A RANDOMİSED CONTROL TRİAL
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
aerobic exercise
motor performance
cognitive performance
Lead sponsor: Tarsus University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was planned as a randomized controlled study
Primary purpose: TREATMENT

Brief summary: Technology-supported training supports the rehabilitation process by providing high-intensity, repetitive, and task-specific treatment, contributes to the recovery process, and facilitates the restoration of arm function (Bertani et al., 2017). Technology-supported rehabilitation studies for the upper extremity are performed using different devices. THERA-Trainer Tigo is used for the mobilization of individuals with limited mobility after trauma or due to any reason; it is suitable for passive movement training and active movement. Treatment with active-passive exercise devices facilitates rehabilitation with natural and rhythmic movements. It allows almost all patients, from wheelchair users to walkers, to actively participate in bicycle training during the rehabilitation process (Pazo et al., 2017). There are very few studies in the literature examining the relationship between cognitive and motor performance functions of THERA-Trainer-based exercises, and the aim of this study is to provide a preliminary idea in terms of progression to clinicians during the evaluation phase and treatment, to contribute to treatment, and to academic researchers.

Detailed description: Stroke is a leading cause of death and disability worldwide. It can be generally classified as ischemic stroke and hemorrhagic stroke. Ischemic stroke is defined as an infarction of the brain, spinal cord, or retina and accounts for approximately 70% of all strokes. Hemorrhagic stroke occurs as a result of intracerebral hemorrhage and subarachnoid hemorrhage (Campbell et al., 2019).Technology-assisted rehabilitation supports recovery by providing high-intensity, repetitive, and task-specific treatment, facilitating the restoration of upper limb function. Studies on technology-based rehabilitation for upper extremity recovery utilize various devices. The THERA-Trainer Tigo, for instance, is designed to mobilize individuals with restricted movement abilities caused by trauma or other conditions. It is suitable for both passive and active motion training. Therapy with active-passive exercise devices promotes rehabilitation through natural and rhythmic movements. It accommodates a wide range of patients-from wheelchair users to those capable of walking-by enabling nearly all individuals in the rehabilitation process to actively participate in cycling exercises .

However, there is a limited body of research exploring the relationship between cognitive and motor performance functions during THERA-Trainer-based exercises. This study aims to address this gap by providing clinicians with insights into progression during evaluation and treatment phases, enhancing therapeutic strategies, and contributing to the academic knowledge base for researchers.

Eligibility criteria: Inclusion Criteria:

* Having had an ischemic or hemorrhagic stroke for the first time
* Those with a Montreal Cognitive Assessment (MOCA) score above 21,
* Individuals with a functional level below 4 according to the modified Rankin scale (MRS),
* Individuals with upper extremity spasm below 3 according to the modified Ashword scale (MAS)

Exclusion Criteria:

* Montreal Cognitive Assessment (MOCA) score of less than 21,
* Upper extremity spasticy of over 3 according to MAS,
* Patients with subluxation and fracture risk in the shoulder,
* Agnosia or visual impairment,
* Limited joint movement in the hemiplegic side upper extremity,
* Patients who have undergone any botulinum toxin application or surgery in the last 6 months

Primary outcomes:
measure: Mini Mental Test
timeFrame: Eight weeks
measure: Digit Span Test
timeFrame: Eight weeks
measure: Frenchay Arm Test
timeFrame: Eight weeks
measure: Time Up Go Test (TUG)
timeFrame: Eight weeks
measure: Fugl Meyer Assesment
timeFrame: Eight weeks
measure: Five Time Sit to Stand
timeFrame: Eight weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tarsus
country: Turkey
facility: Fatma KÜBRA Çekok
state: Mersi̇n
Study officials:
References: