Cross Education for Upper Extremity Motor Function and Strength in Stroke

NCT06522191 | Completed DMC

• 1 other identifier: 2024/83
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Stroke

Keywords

Cross education; Cross training; Robotic rehabilitation; Upper extremity

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Change Score of Stroke Impact Scale (SIS)

  Baseline, post-intervention (approximately 5 weeks)

• Change Score of Barthel Index (BI)

  Baseline, post-intervention (approximately 5 weeks)

• Adverse Events

  Any adverse event reported during the 5 weeks of intervention protocol.

Study Arms (2)

Cross-Education (CE) Group

EXPERIMENTAL

Participants in the CE group will receive repetitive task practice through a robotic rehabilitation (RR) device on the less-affected upper extremity for 20 minutes, twice a week, for 5 weeks, in addition to a physical therapy (PT) program provided 5 days a week. This CE training will be conducted prior to the RR sessions performed on the more affected UE within the PT intervention to facilitate cross-education and support motor priming. In this study, RR applications will utilize an intelligent feedback RR system.

Other: Physiotherapy Training (PT); Device: Cross-Education Intervention

Control Group

SHAM COMPARATOR

Participants in the control group will be given lower extremity-focused exercises for 20 minutes, twice a week, for 5 weeks before the RR application included in the PT program, in order to eliminate the potential effect of the additional treatment provided in the study.

Other: Physiotherapy Training (PT); Other: Control Intervention

Interventions

Physiotherapy Training (PT) OTHER

Both groups received the same therapist-led standardized PT for 5 days a week including 2 days of RR plus 3 days of conventional rehabilitation (CR) for 5 weeks. RR training will be given 40 min per session using an intelligent feedback robotic system. The system allows patients to move a cursor to targets on a monitor using a unilateral exoskeleton robotic arm and handle, which supports shoulder, elbow, forearm, and optionally multi-joint movements. The system provides visual and auditory feedback, offering exergame training with 1Dimension (D), 2D, and 3D options adjustable to three levels (low to high). Exergames and their parameters will be customized based on each patient's capacity. The CR protocol consists of joint range-of-motion, correct movement, stretching and balance exercises, gait training (walking on level surfaces, stairs), strengthening of antagonist muscle pattern will be provided. Each CR session will last 45 min of active treatment.

Control Group; Cross-Education (CE) Group

Cross-Education Intervention DEVICE

Participants in the CE group will have the less affected upper extremity undergo game-based, unilateral, repetitive movement training using RR to enhance the effectiveness of the training to be provided to the affected side. Similar therapeutic games (exergames) planned for the more affected upper extremity will be selected through the unilateral exoskeleton RR device. As described in the PT section, upper extremity movements will be performed using the robotic arm and handle during the games. The difficulty level will be adjusted by the supervisor physiotherapist based on the grip threshold on the robotic handle, the game's difficulty level (low to high), workspace arrangement before each session, and suspension level according to the patient's needs. An approximately 20-minute program will be implemented, consisting of 8 games, each lasting about 2.5 minutes, tailored to the patient's capacity.

Cross-Education (CE) Group

Control Intervention OTHER

The exercises to be administered in the control intervention will be selected based on the patient's level of impairment but will be planned without progression or intensity increase, and the involvement of the upper extremity will be kept to a minimum. The exercises will include lower limb joint range of motion exercises, weight bearing, weight shifting, and gait training.

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic stroke more than 3 months of stroke onset
• History of first-ever unilateral ischemic or hemorrhagic stroke
• Upper extremity motor impairment; defined by an upper extremity score ≤42 on the Fugl Meyer upper extremity (FM-UE) assessment.
• No excessive spasticity in the affected arm (Modified Ashworth Scale ≤3)
• Having the ability to communicate and understand instructions (Mini-mental state examination ≥ 24)
• Being able to sit without needing any additional support and without leaning on a backrest

You may not qualify if:

• Cardiovascular instability (severe, uncontrolled hypertension, coronary artery disease, etc.)
• Other neurological or musculoskeletal problems that can affect upper extremity functions
• Severe upper extremity pain defined as \>7 on the Visual Analogue Scale
• Botox injections of the upper extremity within 3 months before enrollment

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi

Istanbul, Kadikoy, 34730, Turkey (Türkiye)

Location

Related Publications (2)

• Stoykov ME, Corcos DM, Madhavan S. Movement-Based Priming: Clinical Applications and Neural Mechanisms. J Mot Behav. 2017 Jan-Feb;49(1):88-97. doi: 10.1080/00222895.2016.1250716. Epub 2017 Mar 1.

  PMID: 28277966 BACKGROUND

• Lim H, Madhavan S. Effects of Cross-Education on Neural Adaptations Following Non-Paretic Limb Training in Stroke: A Scoping Review with Implications for Neurorehabilitation. J Mot Behav. 2023;55(1):111-124. doi: 10.1080/00222895.2022.2106935. Epub 2022 Aug 8.

  PMID: 35940590 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Fatih Aykut CAVDAR, BSc

  Istanbul University-Cerrahpasa, Institute of Graduate Studies, Department of Physiotherapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

• Rustem MUSTAFAOGLU, PhD

  Istanbul University-Cerrahpasa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

  STUDY CHAIR

• Belgin ERHAN, PhD

  Physical Medicine and Rehabilitation Department, Faculty of Medicine, Istanbul Medeniyet University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: July 29, 2024
• Primary Completion: March 15, 2025
• Study Completion: May 15, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)