The Efficiency of Robotic Hand Exoskeleton System in Stroke Patients

NCT05958628 | Completed

• 1 other identifier: MarmaraU-FTR-FO-01
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Stroke; Hemiplegia; Exoskeleton Device; Muscle Spasticity; Quality of life

Outcome Measures

Primary Outcomes (1)

• Frenchay Arm Test

  It is a scale that evaluates the motor control skills and functions of the upper extremities of patients in a practical way and takes less than 3 minutes to perform. The patient is asked to perform 5 tasks based on activities of daily living in a sitting position with hands on the table. The maximum score on the scale is 5, with 1 point for each successful task. (The tasks the patient is asked to do are; Fixing the ruler, Holding a cylinder, Lifting the glass, Attaching the latch to the bar, Combing hair)

  5 weeks

Secondary Outcomes (3)

• modified ashworth scale

  5 weeks

• Upper Limb Motor Activity Diary-28

  5 weeks

• Stroke impact scale version 3.0

  5 weeks

Study Arms (2)

Control group

OTHER

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

Other: Conventional physiotherapy

Intervention group

EXPERIMENTAL

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.

Other: Conventional physiotherapy; Other: Robotic Hand Exoskeleton System

Interventions

Conventional physiotherapy 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.

Control group; Intervention group

Robotic Hand Exoskeleton System 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.

Intervention group

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Fatma Ozturk

Istanbul, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Hemiplegia; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Study Officials

• Fatma Öztürk, Msc

  Marmara University

  PRINCIPAL INVESTIGATOR

• Gönül Acar, assoc.prof

  Marmara University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessment will be performed by a investigator who was blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: researcher

Model Details: Two groups; one group will receive conventional physiotherapy and one group will be operated with robotic hand exoskeleton system in addition to conventional physiotherapy.

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: July 24, 2023
• Study Start: August 7, 2023
• Primary Completion: November 17, 2023
• Study Completion: November 30, 2023
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)