Clinical trial NCT05958628: The Efficiency of Robotic Hand Exoskeleton System in Stroke Patients
Official title: The Efficiency of Robotic Hand Exoskeleton System in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Hemiplegia
Exoskeleton Device
Muscle Spasticity
Quality of life
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 36
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups; one group will receive conventional physiotherapy and one group will be operated with robotic hand exoskeleton system in addition to conventional physiotherapy.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Frenchay Arm Test
timeFrame: 5 weeks
Secondary outcomes:
measure: modified ashworth scale
timeFrame: 5 weeks
measure: Upper Limb Motor Activity Diary-28
timeFrame: 5 weeks
measure: Stroke impact scale version 3.0
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Fatma Ozturk
Study officials:
affiliation: Marmara University
name: Fatma Öztürk, Msc
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University
name: Gönül Acar, assoc.prof
role: STUDY_DIRECTOR
References: