Cross Education for Upper Extremity Motor Function and Strength in Stroke
NCT Number: NCT06522191
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stroke
Interventions: OTHER: Physiotherapy Training (PT)|DEVICE: Cross-Education Intervention|OTHER: Control Intervention
Sponsor: Istanbul University - Cerrahpasa (IUC)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 36
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-24
Completion Date: 2025-05-15
Locations: Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi, Istanbul, Kadikoy, 34730, Turkey

Summary:
Stroke is the leading cause of disability and mortality worldwide. The impact of stroke on the upper extremity functions is a common and important cause of long-term disability. Indeed, six months after the stroke, a considerable amount of patients are still unable to incorporate the affected upper limb into their daily activities. On the other hand, weaknesses are also observed in the "apparently normal" ipsilateral side of the lesion due to the presence of corticospinal fibers that do not cross to the contralateral side of the medulla.

This study aims to investigate the effects of cross-education (CE) using robotic rehabilitation on upper extremity motor function and strength in patients with stroke. Secondary objectives include assessing quality of life and activities of daily living.

Researchers will compare CE using robotic rehabilitation to the control group (CON) that received lower extremity-focused exercises to see if CE works to enhance rehabilitation outcomes.

Participants will receive 20 min, twice weekly CE (to the less affected upper limb) or CON before the RR intervention included in the PT intervention administered 5 days in a week for 5 weeks. They will be evaluated using the relevant outcomes at the beginning and the end of the study (5th week).

Primary Outcome Measures: Change Score of Fugl-Meyer Assessment - Upper Extremity (FM-UE), We will use the upper extremity subscale of the Fugl-Meyer Assessment (FM-UE), a scale sensitive to therapeutic changes in the post-stroke period, to evaluate motor impairment. The FM-UE assesses movements and reflexes of the shoulder, elbow, forearm, wrist, fingers, ranging from proximal to distal and from synergistic to isolated voluntary movements. There are 33 upper extremity items, and the score ranges from 0 to 66, with higher scores indicating better performance. Each item in the FM-UE is rated on a 3-point ordinal scale (0= cannot perform, 1= performs partially, 2= performs fully). The FM-UE has excellent reliability and validity in stroke patients., Baseline, post-intervention (approximately 5 weeks)|Change Score of Action Research Arm Test (ARAT), Upper extremity motor function will be measured by the ARAT. It includes 19 items divided into four subscales (grasp, grip, pinch, and gross movement subscales) that encompass the main aspects of arm and hand use in daily activities, with a total score ranging from 0 to 57, where higher scores indicate better performance. Most items evaluate the ability to grasp objects of different shapes and sizes and move them to various vertical or horizontal positions. Each item is scored on a 4-point scale (0: cannot perform any part of the task; 1: performs the task partially; 2: completes the task but with abnormal movement components or body posture, or the task takes more than 5 seconds but less than 1 minute to complete; 3: completes the task normally within the 5-second time limit). During the assessment, the time taken for the patient to complete each task will be measured using a stopwatch, and the patient will be observed throughout the task to assign a score based on their performance., Baseline, post-intervention (approximately 5 weeks)|Change Score of Box and Block Test (BBT), The BBT test will be used to measure unilateral gross manual dexterity. It primarily evaluates gross motor function. There are 150 piece 2.5 cm³ blocks in a test box. The patient will be asked to grasp as many cube blocks as possible from the compartment of the side being tested and transfer them one by one over a barrier to the other compartment (horizontal adduction) within one minute. The instruction given to patients is: "I want to see how quickly you can pick up a block with your right (or left) hand and transfer it to the other side, one at a time". The score of the test is determined by the number of blocks correctly transferred to the other compartment within one minute., Baseline, post-intervention (approximately 5 weeks)|Change Score of Isometric Grip Strength, The isometric hand grip strength of both sides will be measured using a hydraulic hand dynamometer. The participant will be asked to squeeze the dynamometer for a trial attempt. When the participant is ready, they will squeeze the dynamometer with maximum isometric contraction for 5 seconds. The participant should be encouraged to exert maximum effort. The purpose of the trial attempt is to ensure that the participant understands the procedure. After the trial attempt, the participant will be instructed to squeeze as hard as possible. Both sides will be evaluated three times with one-minute rest intervals between each attempt, and the average of the three measurements will be taken. The patient will be in a seated position with the shoulder adducted, elbow flexed at 90°, forearm, and wrist in a neutral position. Support against gravity will be provided as needed to maintain the position., Baseline, post-intervention (approximately 5 weeks)|Change Score of Isometric Muscle Strength, To evaluate the maximum isometric muscle strength of the elbow flexors and extensors on both sides, a Lafayette hand dynamometer (Model 01163, Lafayette Instrument Co, Lafayette, Indiana) will be used. In the study, for the assessment of elbow flexor and extensor muscle strength, the patient will be positioned supine with the shoulder, forearm, and wrist in a neutral position (0°), the elbow at 90° flexion, and the fingers in a flexed position. The dynamometer pads will be placed and secured proximally on the radial and ulnar styloid processes to measure elbow flexion and extension strength, respectively. Continuous verbal encouragement will be provided during the test. Patients will be asked to perform a maximum isometric contraction, and a submaximal contraction will be performed before the evaluation to prepare for the assessment. A total of three assessments will be conducted with 30-second rest intervals, and the average of the data (in kg) will be recorded., Baseline, post-intervention (approximately 5 weeks)
Secondary Outcome Measures: Change Score of Stroke Impact Scale (SIS), The Turkish version of the SIS 3.0 will be used to evaluate function and health-related quality of life (HRQoL). The questions are based on subjective reports across eight clinically relevant domains. It consists of two parts. The first part is the primary scale of the SIS, which evaluates multidimensional HRQoL, including strength, hand function, activities of daily living (ADL)/ instrumental ADL, mobility, communication, emotion, memory/thinking, and social participation. It comprises 59 items, each scored using a 5-point Likert scale based on the difficulty perceived over the past week. The second part of the SIS includes an assessment of stroke recovery using a scale ranging from 0 to 100 (0: no recovery, 100: full recovery). Each domain score is converted to a score out of 100, and the mean scores of all domains are used to represent the HRQoL. The formula used for converting each domain score is 'Domain Score = \[(actual - possible raw score) / possible raw score range\] x 100'., Baseline, post-intervention (approximately 5 weeks)|Change Score of Barthel Index (BI), The level of independence in patients' activities of daily living will be determined by the Barthel Index (BI). It consists of ten items assessing mobility and self-care activities of daily living. The scoring range is from 0 to 100; a score range of 0 to 20 represents total dependency; 21 to 61 indicates severe dependency; 62 to 90 indicates moderate dependency; 91 to 99 indicates mild dependency, and a score of 100 represents complete independence., Baseline, post-intervention (approximately 5 weeks)|Adverse Events, Any adverse event or near miss is required to be reported., Any adverse event reported during the 5 weeks of intervention protocol.