Effects of a Computerised Exercise System on Functionality of the Arm,Cognition and Quality of Life in Stroke Patients

NCT04036422 | Completed

• 1 other identifier: KA19/192
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke occurs as a result of blood vessels of the brain becoming blocked or bleeding which in turn can result in loss of function in the limbs. Rehabilitation of patients following stroke includes repetitive, task based exercises to help regain normal limb function. Developments in stroke rehabilitation have resulted in more and more therapeutic options being available for inclusion in the treatment plan of stroke patients. The benefits of computerised task based arm and hand rehabilitation exercises in stroke rehabilitation are well known. Computer based rehabilitation supports the stroke patient in performing high intensity, multiple repetition exercises and in doing so encourages the regeneration of brain cells. In addition, it is believed that the stimulating environment provided by computerised exercise programs encourages the ability to problem solve and perform tasks. However, the effects of such computer based treatments on cognition have rarely been studied. In Turkey to date there are no community based, task specific computerised exercise programmes available to stroke sufferers. Such systems may provide inpatient and community based stroke sufferers with a practical and economical therapeutic option as a part of stroke rehabilitation. Moreover, this may provide the patient with a mode of ongoing, long term therapeutic exercise and maintenance of skills acquired in the hospital rehabilitation period shortly after stroke. The aim of this study was to investigate the benefits of computer based, task specific exercises when compared to conventional rehabilitation alone on arm and hand function, quality of life and cognition in stroke patients.

Conditions

Stroke; Neuronal Plasticity; Hemiplegia

Keywords

stroke; neuronal plasticity; cognition; hemiplegia; Remote rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in upper extremity impairment

  The Fugl-Meyer Upper Extremity (FMUE) Scale is a widely used and highly recommended stroke-specific, performance-based measure of impairment. It is designed to assess reflex activity, movement control and muscle strength in the upper extremity of people with post-stroke hemiplegia. It has been extensively used as an outcome measure in rehabilitation trials and to record poststroke recovery, particularly in the USA. The FMUE Scale comprises 33 items, each scored on a scale of 0 to 2, where 0 = cannot perform, 1 = performs partially and 2 = performs fully. It is free, requires only household items for testing, and takes up to 30 minutes to administer.The total score ranges from 0-66 where 66. The higher the score the less the level of impairment.

  Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment).

Secondary Outcomes (4)

• Change in motor activity

  Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment).

• Mini mental state examination (MMSE)

  Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment).

• Montreal Cognitive Assessment (MoCA) test

  Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment).

• Stroke Specific Quality of Life (SS-QOL) Scale

  Before treatment sessions begin and after twenty hours of conventional physical therapy and 28 hours of occupational therapy have been completed (i.e. four weeks after the initial onset of treatment).

Study Arms (2)

Computer based exercise group

EXPERIMENTAL

The fifteen patients included in this arm of the study will receive a one hourly 'one-on-one' session of conventional physical therapy five days a week to a total of twenty hours over a four week period. In addition to this, these patients will receive half an hour of conventional occupational therapy and half an hour of Rejoyce computerized exercise seven days a week to a total of twenty eight hours over a four weeks period.

Device: Rejoyce (Rehabilitation Joystick for Computerized Exercise); Other: Conventional physical therapy; Other: Occupational therapy

Conventional treatment group

ACTIVE COMPARATOR

The fifteen patients included in this arm of the study will receive a one hourly 'one-on-one' session of conventional physical therapy five days a week, to a total of twenty hours over a four week period. In addition to this, patients in this group will receive one hourly sessions of conventional occupational therapy seven days a week to a total of twenty eight hours over a four week period.

Device: Rejoyce (Rehabilitation Joystick for Computerized Exercise); Other: Conventional physical therapy; Other: Occupational therapy

Interventions

Rejoyce (Rehabilitation Joystick for Computerized Exercise) DEVICE

Rejoyce (Rehabilitation Joystick for Computerized Exercise), is a computer game based task specific exercise system developed by Rehabtronics Inc. for use as part of the treatment of stroke and spinal cord injury patients. Rejoyce aims to improve upper extremity and hand function by encouraging neuroplasticity through repeated task specific games.

Computer based exercise group; Conventional treatment group

Conventional physical therapy OTHER

A physical therapy session customised to the patient's needs overseen by a physical medicine and rehabilitation specialist and conducted by a physiotherapist which includes range of motion, neurophysiological and strengthening exercises, balance and coordination training and walking exercises.

Computer based exercise group; Conventional treatment group

Occupational therapy OTHER

Task based exercises overseen by a physical medicine and rehabilitation specialist and conducted by an occupational therapist aimed at improving upper arm dexterity, coordination and strength.

Computer based exercise group; Conventional treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18-80 years
• Admitted to our PRM Department with a diagnosis of hemiplegia secondary to stroke for rehabilitation
• Upper extremity and hand Brunnstrom staging of ≥3.
• MMSE score of ≥23.

You may not qualify if:

• Presence of disability of the arms and hand which affects upper extremity motor function prior to stroke
• Presence of diplegia
• Presence of neglect
• Presence of visual field defect
• Presence of loss of hearing
• Presence of spasticity in the hemiplegic upper extremity and hand of grade 3 and above according to the Modified Ashworth Scale
• Presence of acute musculoskeletal pain which will affect exercise participation
• Inability to sit upright in a chair for 30 minutes.
• Those who are clinically unstable due to comorbidities.

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University Faculty of Medicine, Ankara Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (20)

• Kowalczewski J, Prochazka A. Technology improves upper extremity rehabilitation. In: Green AM, Chapman CE, Kalaska JF, Lepore F (eds.) Enhancing Performance for Action and Perception. Elsevier, Amsterdam, 2011b, pp.147-159

  BACKGROUND

• Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.

  PMID: 24505342 BACKGROUND

• Adkins DL, Boychuk J, Remple MS, Kleim JA. Motor training induces experience-specific patterns of plasticity across motor cortex and spinal cord. J Appl Physiol (1985). 2006 Dec;101(6):1776-82. doi: 10.1152/japplphysiol.00515.2006. Epub 2006 Sep 7.

  PMID: 16959909 BACKGROUND

• Risedal A, Mattsson B, Dahlqvist P, Nordborg C, Olsson T, Johansson BB. Environmental influences on functional outcome after a cortical infarct in the rat. Brain Res Bull. 2002 Jul;58(3):315-21. doi: 10.1016/s0361-9230(02)00796-7.

  PMID: 12128159 BACKGROUND

• Taub E, Uswatte G, Elbert T. New treatments in neurorehabilitation founded on basic research. Nat Rev Neurosci. 2002 Mar;3(3):228-36. doi: 10.1038/nrn754.

  PMID: 11994754 BACKGROUND

• Paolucci S, Grasso MG, Antonucci G, Bragoni M, Troisi E, Morelli D, Coiro P, De Angelis D, Rizzi F. Mobility status after inpatient stroke rehabilitation: 1-year follow-up and prognostic factors. Arch Phys Med Rehabil. 2001 Jan;82(1):2-8. doi: 10.1053/apmr.2001.18585.

  PMID: 11239278 BACKGROUND

• Johansson T, Wild C. Telerehabilitation in stroke care--a systematic review. J Telemed Telecare. 2011;17(1):1-6. doi: 10.1258/jtt.2010.100105. Epub 2010 Nov 19.

  PMID: 21097560 BACKGROUND

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  PMID: 23319181 BACKGROUND

• Kowalczewski J, Chong SL, Galea M, Prochazka A. In-home tele-rehabilitation improves tetraplegic hand function. Neurorehabil Neural Repair. 2011 Jun;25(5):412-22. doi: 10.1177/1545968310394869. Epub 2011 Mar 3.

  PMID: 21372246 BACKGROUND

• Kowalczewski J, Gritsenko V, Ashworth N, Ellaway P, Prochazka A. Upper-extremity functional electric stimulation-assisted exercises on a workstation in the subacute phase of stroke recovery. Arch Phys Med Rehabil. 2007 Jul;88(7):833-9. doi: 10.1016/j.apmr.2007.03.036.

  PMID: 17601461 BACKGROUND

• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

  PMID: 1202204 BACKGROUND

• Gungen C, Ertan T, Eker E, Yasar R, Engin F. [Reliability and validity of the standardized Mini Mental State Examination in the diagnosis of mild dementia in Turkish population]. Turk Psikiyatri Derg. 2002 Winter;13(4):273-81. Turkish.

  PMID: 12794644 BACKGROUND

• Sullivan KJ, Tilson JK, Cen SY, Rose DK, Hershberg J, Correa A, Gallichio J, McLeod M, Moore C, Wu SS, Duncan PW. Fugl-Meyer assessment of sensorimotor function after stroke: standardized training procedure for clinical practice and clinical trials. Stroke. 2011 Feb;42(2):427-32. doi: 10.1161/STROKEAHA.110.592766. Epub 2010 Dec 16.

  PMID: 21164120 BACKGROUND

• Kowalczewski J, Ravid E, Prochazka A. Fully-automated test of upper-extremity function. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:7332-5. doi: 10.1109/IEMBS.2011.6091710.

  PMID: 22256032 BACKGROUND

• Prochazka A, Kowalczewski J. A fully automated, quantitative test of upper limb function. J Mot Behav. 2015;47(1):19-28. doi: 10.1080/00222895.2014.953442.

  PMID: 25575220 BACKGROUND

• Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

  PMID: 15817019 BACKGROUND

• Shen YJ, Wang WA, Huang FD, Chen J, Liu HY, Xia YL, Han M, Zhang L. The use of MMSE and MoCA in patients with acute ischemic stroke in clinical. Int J Neurosci. 2016;126(5):442-7. doi: 10.3109/00207454.2015.1031749. Epub 2015 Sep 25.

  PMID: 26000804 BACKGROUND

• Williams LS, Weinberger M, Harris LE, Clark DO, Biller J. Development of a stroke-specific quality of life scale. Stroke. 1999 Jul;30(7):1362-9. doi: 10.1161/01.str.30.7.1362.

  PMID: 10390308 BACKGROUND

• Hakverdioglu Yont G, Khorshid L. Turkish version of the Stroke-Specific Quality of Life Scale. Int Nurs Rev. 2012 Jun;59(2):274-80. doi: 10.1111/j.1466-7657.2011.00962.x. Epub 2011 Nov 23.

  PMID: 22591101 BACKGROUND

• Parker VM, Wade DT, Langton Hewer R. Loss of arm function after stroke: measurement, frequency, and recovery. Int Rehabil Med. 1986;8(2):69-73. doi: 10.3109/03790798609166178.

  PMID: 3804600 BACKGROUND

MeSH Terms

Conditions

Stroke; Hemiplegia

Interventions

Occupational Therapy

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Selin Ozen, MBBS,BSc

  Baskent University Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The primary investigator will be blind to the treatment received by the patients and will carry out all patient evaluations before and after the treatment program is completed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical and Rehabilitation Medicine Specialist

Model Details: The patients will be randomized into one of two groups (fifteen patients in each group) using the Random Allocation Software. All patients will receive a one hourly 'one-on-one' session of physiotherapy five days a week to a total of twenty hours (four weeks) which includes strengthening, balance and walking exercises. In addition to this, one group will receive half and hour of conventional occupational therapy which includes task based exercises aimed at improving upper arm dexterity, coordination and strength seven days a week to a total of twenty eight hours (four weeks), whereas patients in the other group will receive half an hour of Rejoyce computerized exercise to a total of twenty eight hours (four weeks).

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: July 29, 2019
• Study Start: August 1, 2019
• Primary Completion: November 15, 2020
• Study Completion: November 15, 2020
• Last Updated: May 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)