Thera-Trainer Exercise Effects on Motor and Cognitive Outcomes in Stroke: RCT

NCT06938477 | Completed

• 1 other identifier: 2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; aerobic exercise; motor performance; cognitive performance

Outcome Measures

Primary Outcomes (6)

• Mini Mental Test

  The Mini Mental State Examination (MMSE) is a widely used tool for assessing cognitive function, particularly in screening for dementia and monitoring cognitive changes over time. It evaluates different cognitive domains, including orientation, registration, attention, calculation, recall, language, and visual-spatial skills.

  Eight weeks

• Digit Span Test

  The Digit Span Test is a cognitive assessment tool used to evaluate working memory, attention, and concentration. It is often part of broader neuropsychological evaluations and can assess both forward and backward digit span.

  Eight weeks

• Frenchay Arm Test

  The Frenchay Arm Test involves 5 tasks, each graded as pass (1 point) or fail (0 points) based on the patient's ability to complete the task. The tasks progress in difficulty and assess various aspects of upper limb function.

  Eight weeks

• Time Up Go Test (TUG)

  The Timed Up and Go Test (TUG) is a simple and widely used assessment tool to evaluate mobility, balance, and functional independence. It is particularly useful for identifying fall risk in older adults and individuals with neurological or musculoskeletal impairments.

  Eight weeks

• Fugl Meyer Assesment

  The test examines reflex activity, voluntary movements within, partially out and independent of synergies (22). The scale includes 33 items divided into 4 subscales: shoulder/elbow (A, 18 items), wrist (B, 5 items), hand (C, 7 items) and coordination/ speed (D, 3 items). Each item is scored on an ordinal 3-point scale, where 2 points are assigned when the movement is performed fully, 1 point when performed partially, and 0 points when the movement cannot be performed. A total score of 66 indicates better sensorimotor function

  Eight weeks

• Five Time Sit to Stand

  The Five Times Sit-to-Stand Test (FTSST) is a simple, reliable, and functional test used to assess lower limb strength, balance, and mobility. It is widely applied in clinical and research settings for evaluating physical performance in various populations, including older adults and individuals with neuromuscular conditions.The individual sits in a standard chair (seat height \~43-45 cm) without armrests.The chair is placed against a wall or a stable surface to prevent movement.The participant starts seated with their back against the chair and feet flat on the floor, arms crossed over the chest.On the signal "Go," they are instructed to stand up fully and sit back down as quickly as possible, repeating this motion five times.The test begins at the word "Go" and ends when the participant fully stands after the fifth repetition.A stopwatch is used to record the total time taken.

  Eight weeks

Study Arms (2)

THERA-TRAINER BASED EXERCISES

EXPERIMENTAL

Participants in the exercise arm will engage in structured, Thera-Trainer-based exercise programs tailored to their motor and cognitive rehabilitation needs. The intervention focuses on combining motor and cognitive tasks to maximize recovery outcomes.

Other: THERA-TRAINER BASED EXERCISES

Functional Stroke Training

EXPERIMENTAL

To enhance motor recovery, functional independence, and cognitive performance in stroke patients

Other: FUNCTIONAL STROKE TRAİNİNG

Interventions

THERA-TRAINER BASED EXERCISES OTHER

The interventions will carried out two days a week and 40 minutes for eight weeks

THERA-TRAINER BASED EXERCISES

FUNCTIONAL STROKE TRAİNİNG OTHER

he interventions will carried out two days a week and 40 minutes for eight weeks

Functional Stroke Training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Tarsus University: lead

Study Sites (1)

Fatma KÜBRA Çekok

Tarsus, Mersin, 33400, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Study participants are unaware of their assigned grou
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst.Prof

Model Details: The study was planned as a randomized controlled study

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 22, 2025
• Study Start: May 19, 2024
• Primary Completion: March 15, 2025
• Study Completion: June 15, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Locations

TU (1)