Robotic Versus Conventional Therapy For Post-Stroke Hand Motoric Recovery

NCT06155058 | Unknown

• 1 other identifier: 2411232122
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

This clinical trial aims to compare the effectiveness of Robotic versus conventional mirror therapy among post-stroke patients. The main questions it aims to answer are:

• Effectiveness of both interventions in hand motoric recovery across time
• Effectiveness of both interventions in functional outcomes across time
• Clinical outcome difference between both interventions Participants will be allocated into either a robotic group as the main intervention or a mirror therapy group as the active comparator. A serial follow-up will be conducted to assess the selected clinical outcome and differences in outcome

Conditions

Stroke; Physical Disability; Upper Extremity Paresis

Keywords

Robotic Therapy; Mirror Therapy; Post-Stroke; Upper Extremities; Motoric Function; Functional Outcome

Outcome Measures

Primary Outcomes (2)

• FMA-UE Score

  a motoric assessment with each score range from 0-2 with a total score range from 0-66. Higher score indicates better and free movement

  changes of FMA-UE score from pre-intervention to six weeks after intervention

• NHPT value

  an assessment for finger dexterity and coordination where the time of the subject to accomplish task will be recorded. Average healthy adult male completed the NHPT in 19.0 seconds (SD 3.2) with the right hand, and in 20.6 seconds (SD 3.9) with the left hand. For healthy adult women, the NHPT was completed in 17.9 seconds (SD 2.8) and 19.6 seconds (SD 3.4) with the right and left hands, respectively.

  changes of NHPT values from pre-intervention to six weeks after intervention

Study Arms (2)

Robotic Mirror Therapy

EXPERIMENTAL

Serial training with the help of exoskeletal robot therapy

Procedure: SYREBO

Conventional Mirror Therapy

ACTIVE COMPARATOR

Serial training with the help of physical therapist

Procedure: Conventional Mirror Method

Interventions

SYREBO PROCEDURE

Serial ADL training of upper extremities with robotic aid

Robotic Mirror Therapy

Conventional Mirror Method PROCEDURE

Serial ADL training of upper extremities assisted by physical therapist

Conventional Mirror Therapy

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 20 - 85 years.
• Non-haemorrhagic stroke/infarction with onset more than 3 months from the onset of the attack.
• Patients with unilateral upper limb hemiparesis.
• Modified Ashworth Scale (MAS) on fingers and hands \<3
• The patient has not undergone mirror therapy treatment before.
• Patients who are able to understand informed consent to participate in research.
• The patient had a Radiology imaging of the head at the time of stroke onset.

You may not qualify if:

• Patients with severe spasticity or contractures of the upper extremities.
• Patients with infarction/bleeding with extensive lesions covering 2 hemispheres.
• The patient has severe cognitive impairment that will interfere with the research objectives (MMSE score \>24).
• Patients post Digital Subtraction Angiography (DSA) procedures in the last 2 months.
• Patients with a history of seizures or epilepsy.
• Patients with visual field deficits or severe visual impairment.
• Patients who are unable to sit upright without assistance.
• Other uncontrolled medical conditions (musculoskeletal, neuromuscular, cardiorespiratory) that may interfere with the ability to exercise.
• Dropout criteria:
• Patients were excluded from the study if:
• Participant dies.
• Participants take part in the exercise \<3 times for 2 consecutive weeks.
• The participant refuses to continue the training session.
• Participants experience hemodynamic disorders during the training program phase.
• Participants experience neurological disorders during the training program phase.

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (3)

Cerebellum Clinic

Makassar, South Sulawesi, 90231, Indonesia

Location

Hasanuddin University, Faculty of Medicine

Makassar, South Sulawesi, 90245, Indonesia

Location

Wahidin Sudirohusodo General Hospital

Makassar, South Sulawesi, 90245, Indonesia

Location

Related Publications (8)

• Beom J, Koh S, Nam HS, Kim W, Kim Y, Seo HG, Oh BM, Chung SG, Kim S. Robotic Mirror Therapy System for Functional Recovery of Hemiplegic Arms. J Vis Exp. 2016 Aug 15;(114):54521. doi: 10.3791/54521.

  PMID: 27583794 BACKGROUND

• Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.

  PMID: 3809245 BACKGROUND

• Chowdhury, Z., 2018. Effectiveness of Mirror Therapy on hand function improvement among patients with chronic stroke. IOSR Journal of Nursing and Health Science (IOSR-JNHS) e-ISSN: 2320-1959.p- ISSN: 2320-1940 Volume 4, Issue 6 Ver. V (Nov. - Dec. 2015), PP 01-04

  BACKGROUND

• Hijikata N, Kawakami M, Ishii R, Tsuzuki K, Nakamura T, Okuyama K, Liu M. Item Difficulty of Fugl-Meyer Assessment for Upper Extremity in Persons With Chronic Stroke With Moderate-to-Severe Upper Limb Impairment. Front Neurol. 2020 Nov 16;11:577855. doi: 10.3389/fneur.2020.577855. eCollection 2020.

  PMID: 33304304 BACKGROUND

• Lee MM, Cho HY, Song CH. The mirror therapy program enhances upper-limb motor recovery and motor function in acute stroke patients. Am J Phys Med Rehabil. 2012 Aug;91(8):689-96, quiz 697-700. doi: 10.1097/PHM.0b013e31824fa86d.

  PMID: 22469877 BACKGROUND

• Nogueira NGHM, Parma JO, Leao SESA, Sales IS, Macedo LC, Galvao ACDR, de Oliveira DC, Murca TM, Fernandes LA, Junqueira C, Lage GM, Ferreira BP. Mirror therapy in upper limb motor recovery and activities of daily living, and its neural correlates in stroke individuals: A systematic review and meta-analysis. Brain Res Bull. 2021 Dec;177:217-238. doi: 10.1016/j.brainresbull.2021.10.003. Epub 2021 Oct 7.

  PMID: 34626693 BACKGROUND

• Rothgangel AS, Braun SM, Beurskens AJ, Seitz RJ, Wade DT. The clinical aspects of mirror therapy in rehabilitation: a systematic review of the literature. Int J Rehabil Res. 2011 Mar;34(1):1-13. doi: 10.1097/MRR.0b013e3283441e98.

  PMID: 21326041 BACKGROUND

• Schrader M, Sterr A, Kettlitz R, Wohlmeiner A, Buschfort R, Dohle C, Bamborschke S. The effect of mirror therapy can be improved by simultaneous robotic assistance. Restor Neurol Neurosci. 2022;40(3):185-194. doi: 10.3233/RNN-221263.

  PMID: 35848045 BACKGROUND

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Steven Kurniawan, MD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Nuralam Sam, MD. Ph.D

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Husnul Mubarak, MD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Yose Waluyo, MD. PhD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Andi A Zainuddin, MD.Phd

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Andi A Mochtar, Dr. Eng

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Kurniawan, MD

CONTACT

+6281319912162; stvn.aupp@gmail.com

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: Assistant Lecturer

Model Details: The intervention group will be the robotic and the active comparator will be the conventional mirror therapy exercise group

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 4, 2023
• Study Start: December 1, 2023
• Primary Completion: February 28, 2024
• Study Completion: March 30, 2024
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (3)