Clinical trial NCT06027125: Long Term Effects of Action Observation Therapy and Mirror Therapy on Upper Limb Functions
Official title: Long Term Effects of Action Observation Therapy and Mirror Therapy on Upper Limb Functional and Fine Motor Outcomes After Subacute Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Action observation therapy , Mirror therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There will be a long term effects of action observation therapy and mirror therapy on upper limb functional outcomes after subacute stroke.

Detailed description: However, no study is conducted to check the retention rate of both therapies. My study will check the retention rate of these interventions in stroke. If we are able to know long lasting effects of this particular regime, we can incorporate this cost-effective intervention into our clinical setups for stroke rehabilitation.

Eligibility criteria: Inclusion Criteria:

* Both male and female
* 1 to 6 months since unilateral stroke onset
* Age between 40 and 70 years.
* Baseline score of the FMA motor score between 20 and 40
* Ability to follow the study instructions according to Montreal cognitive scale and score should be \>24.

Exclusion Criteria:

* Patients with depression who will be unable to cooperate during treatment and Cardiopulmonary diseases which could hinder their ability to participate in rehabilitation
* Visual and auditory abnormalities
* Major medical problems or comorbidities that influenced the usage of the upper limbs or caused severe pain.

Primary outcomes:
measure: Fugel Meyer assessment of upper limb
timeFrame: 4,5,6,7,8 week
measure: Functional Independence Measure
timeFrame: 4,5,6,7,8 week
measure: Short form of the Stroke Impact Scale (SF-SIS)
timeFrame: 4,5,6,7,8 week
measure: Wolf motor function test
timeFrame: 4,5,6,7,8 week
Secondary outcomes:
Other outcomes:
Locations:
city: Gujrat
country: Pakistan
facility: Mid city Hospital Gujrat
state: Punjab
Study officials:
affiliation: Riphah International University
name: Ayesha Bashir, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhu M-H, Wang J, Gu X-D, Shi M-F, Zeng M, Wang C-Y, et al. Effect of action observation therapy on daily activities and motor recovery in stroke patients. International journal of nursing sciences. 2015;2(3):279-82
citation: Bhasin A, Padma Srivastava MV, Kumaran SS, Bhatia R, Mohanty S. Neural interface of mirror therapy in chronic stroke patients: a functional magnetic resonance imaging study. Neurol India. 2012 Nov-Dec;60(6):570-6. doi: 10.4103/0028-3886.105188.
citation: Harmsen WJ, Bussmann JB, Selles RW, Hurkmans HL, Ribbers GM. A Mirror Therapy-Based Action Observation Protocol to Improve Motor Learning After Stroke. Neurorehabil Neural Repair. 2015 Jul;29(6):509-16. doi: 10.1177/1545968314558598. Epub 2014 Nov 21.
citation: Dohle C, Pullen J, Nakaten A, Kust J, Rietz C, Karbe H. Mirror therapy promotes recovery from severe hemiparesis: a randomized controlled trial. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):209-17. doi: 10.1177/1545968308324786. Epub 2008 Dec 12.
citation: Gandhi DB, Sterba A, Khatter H, Pandian JD. Mirror Therapy in Stroke Rehabilitation: Current Perspectives. Ther Clin Risk Manag. 2020 Feb 7;16:75-85. doi: 10.2147/TCRM.S206883. eCollection 2020.
citation: Buccino G. Action observation treatment: a novel tool in neurorehabilitation. Philos Trans R Soc Lond B Biol Sci. 2014 Apr 28;369(1644):20130185. doi: 10.1098/rstb.2013.0185. Print 2014.
citation: Franceschini M, Ceravolo MG, Agosti M, Cavallini P, Bonassi S, Dall'Armi V, Massucci M, Schifini F, Sale P. Clinical relevance of action observation in upper-limb stroke rehabilitation: a possible role in recovery of functional dexterity. A randomized clinical trial. Neurorehabil Neural Repair. 2012 Jun;26(5):456-62. doi: 10.1177/1545968311427406. Epub 2012 Jan 10.
citation: Hsieh YW, Lin YH, Zhu JD, Wu CY, Lin YP, Chen CC. Treatment Effects of Upper Limb Action Observation Therapy and Mirror Therapy on Rehabilitation Outcomes after Subacute Stroke: A Pilot Study. Behav Neurol. 2020 Jan 2;2020:6250524. doi: 10.1155/2020/6250524. eCollection 2020.
citation: Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
citation: Yavuzer G, Selles R, Sezer N, Sutbeyaz S, Bussmann JB, Koseoglu F, Atay MB, Stam HJ. Mirror therapy improves hand function in subacute stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2008 Mar;89(3):393-8. doi: 10.1016/j.apmr.2007.08.162.
citation: Feigin V, Carter K, Hackett M, Barber PA, McNaughton H, Dyall L, Chen MH, Anderson C; Auckland Regional Community Stroke Study Group. Ethnic disparities in incidence of stroke subtypes: Auckland Regional Community Stroke Study, 2002-2003. Lancet Neurol. 2006 Feb;5(2):130-9. doi: 10.1016/S1474-4422(05)70325-2.
citation: Centers for Disease Control and Prevention (CDC). Prevalence of stroke--United States, 2006-2010. MMWR Morb Mortal Wkly Rep. 2012 May 25;61(20):379-82.
citation: Hewer RL. Stroke rehabilitation. Cerebral Arterial Disease Edinburgh, Scotland, Churchill Livingstone. 1976:262-80