Cross Education for Upper Extremity Motor Function and Strength in Stroke

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

Interventions

OTHER

Physiotherapy Training (PT)

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.

DEVICE

Cross-Education Intervention

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.

OTHER

Control Intervention

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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa

  lead OTHER

Principal Investigators

• Fatih Aykut CAVDAR, BSc · Istanbul University-Cerrahpasa, Institute of Graduate Studies, Department of Physiotherapy and Rehabilitation

• Rustem MUSTAFAOGLU, PhD · Istanbul University-Cerrahpasa, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

• Belgin ERHAN, PhD · Physical Medicine and Rehabilitation Department, Faculty of Medicine, Istanbul Medeniyet University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-29

Primary Completion

2025-03-15

Completion

2025-05-15

Countries

• Turkey (Türkiye)

Study Locations