The Efficiency of Robotic Hand Exoskeleton System in Stroke Patients

NCT ID: NCT05958628

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-07
• Study Completion Date: 2023-11-30

Brief Summary

The aim of our study is to investigate the effects of the robotic hand exoskeleton, on the spasticity, motor control skills, level of daily living activity, quality of life and functional independence of stroke patients.

Detailed Description

Stroke is a condition that occurs as a result of an ischemic or hemorrhagic intracranial vascular event, is the third leading cause of death in the world and can lead to disability. Depending on the localization of brain damage after stroke, it is possible to talk about different prognoses and therefore different functional losses in the lower extremities, upper extremities and hand and wrist.

Today, various neurophysiological approaches, exercise strategies, electrotherapy modalities and assistive devices are used in the rehabilitation program suitable for the patient after stroke. In addition to these, robot-assisted therapy is gaining a place as an innovative approach in stroke rehabilitation with the developments in technology. Robot-assisted therapy is thought to both facilitate and intensify treatment after stroke and increase motor development.

The normal functions of the hand, which has many abilities and a complex structure, is extremely important to lead a free and active life. When the literature is examined, the success rate in the recovery of skills and functional recovery of the hand in stroke rehabilitation is low compared to the lower extremity and shoulder joint. More interventions are needed to increase the functional recovery of the hand. Studies should be conducted on robot-assisted treatment methods that allow active and passive exercises in the hand after stroke and contribute to neuroplasticity with an intensified and standardized program.

Our aim in this study is to investigate the efficacy of the Robotic Hand Exoskeleton System developed at Marmara University in order to reduce the physiotherapy process and increase the responses of patients who have partially lost their hand functions due to stroke and need rehabilitation in stroke patients.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Participants in this group will receive a conventional physiotherapy program 3 times a week for 5 weeks, each session lasting 1 hour.

Group Type: OTHER

Conventional physiotherapy

Intervention Type: OTHER

The treatment program was designed in line with the patients' compliance, functional capacities and rehabilitation goals as neurodevelopmental therapy based on the ability to adapt to change, reorganization and healing in the brain by focusing on neuroplasticity from neurodevelopmental treatment approaches; Proprioceptive neuromuscular facilitation techniques to increase selective and voluntary movement; functional exercises to increase motor control skills, stretching exercises for spasticity and neuromuscular electrical stimulation.

The control group received conventional physiotherapy exercises for 45 minutes and neuromuscular electrical stimulation for 15 minutes.

Intervention group

Participants in this group will receive Robotic Hand Exoskeleton System for 10 minutes in addition to 50 minutes of conventional physiotherapy 3 times a week for 5 weeks.

Group Type: EXPERIMENTAL

Conventional physiotherapy

Intervention Type: OTHER

The treatment program was designed in line with the patients' compliance, functional capacities and rehabilitation goals as neurodevelopmental therapy based on the ability to adapt to change, reorganization and healing in the brain by focusing on neuroplasticity from neurodevelopmental treatment approaches; Proprioceptive neuromuscular facilitation techniques to increase selective and voluntary movement; functional exercises to increase motor control skills, stretching exercises for spasticity and neuromuscular electrical stimulation.

The control group received conventional physiotherapy exercises for 45 minutes and neuromuscular electrical stimulation for 15 minutes.

Robotic Hand Exoskeleton System

Intervention Type: OTHER

In the treatment applications with the robotic hand exoskeleton system, which is designed to accelerate the healing process of patients in need of hand rehabilitation, to gain motor skills, to provide strength training and to increase participation in treatment, the patient will be asked to allow the system to move the hand at adjusted angles for 10 minutes and to accompany this movement. In the applications, while the patient is sitting comfortably and safely, the patient will be asked to place the stroke-affected hand into the system. The hand of patients who may have difficulty due to the functional status of the upper extremity and the severity of spasticity will be placed with the help of the physiotherapist. The physiotherapist will be with the patient throughout the application.

Interventions

Conventional physiotherapy

The treatment program was designed in line with the patients' compliance, functional capacities and rehabilitation goals as neurodevelopmental therapy based on the ability to adapt to change, reorganization and healing in the brain by focusing on neuroplasticity from neurodevelopmental treatment approaches; Proprioceptive neuromuscular facilitation techniques to increase selective and voluntary movement; functional exercises to increase motor control skills, stretching exercises for spasticity and neuromuscular electrical stimulation.

The control group received conventional physiotherapy exercises for 45 minutes and neuromuscular electrical stimulation for 15 minutes.

Intervention Type: OTHER

Robotic Hand Exoskeleton System

In the treatment applications with the robotic hand exoskeleton system, which is designed to accelerate the healing process of patients in need of hand rehabilitation, to gain motor skills, to provide strength training and to increase participation in treatment, the patient will be asked to allow the system to move the hand at adjusted angles for 10 minutes and to accompany this movement. In the applications, while the patient is sitting comfortably and safely, the patient will be asked to place the stroke-affected hand into the system. The hand of patients who may have difficulty due to the functional status of the upper extremity and the severity of spasticity will be placed with the help of the physiotherapist. The physiotherapist will be with the patient throughout the application.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Being diagnosed with stroke by a neurologist
• At least 3 months have passed after the stroke
• Mini Mental State Examination score of at least 24
• To be able to maintain sitting balance during working with the robot,
• Having full range of motion in the metacarpophalangeal (MCP), proximal interphalangeal (PIF) and distal interphalangeal (DIF) joints,
• Spasticity in finger flexor and extensor muscles ≤ 3 according to the Modified Ashworth Scale (MAS)
• Being between the ages of 35-85

Exclusion Criteria

• Other neurological or orthopedic problems that may affect upper extremity function,
• Cardiovascular vulnerability (severe uncontrolled hypertension, severe coronary artery disease, unstable angina)
• Behavioral and cognitive conditions that affect treatment and make compliance difficult
• Having botulinum toxin procedure in the last 6 months
• Cardiac pacemakers
• Those with skin ulcers
• Pregnancy
• History of metastatic cancer

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marmara University

OTHER

Sponsor Role: lead

Responsible Party

Fatma Ozturk

researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatma Öztürk, Msc

Role: PRINCIPAL_INVESTIGATOR

Marmara University

Gönül Acar, assoc.prof

Role: STUDY_DIRECTOR

Marmara University

Locations

Fatma Ozturk

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

MarmaraU-FTR-FO-01

Identifier Type: -

Identifier Source: org_study_id