Clinical trial NCT04574687: Effects of Action Observation Therapy on Fine Motor Skills of Upper Limb Functions in Chronic Stroke Patients.
Official title: Effects of Action Observation Therapy on Fine Motor Skills of Upper Limb Functions in Chronic Stroke Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stroke
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted to evaluate the outcomes of action observation therapy on fine motor skills of affected upper limb among patients with chronic stroke.

Detailed description: The data for study will be collected for the duration of 5 months, data will be collected at 1st, 4th, 8th, 12th and then at 16th week of follow up. It is a Randomized Control Trial. Patients will be selected by Consecutive Sampling from Ittefaq Hospital Trust, Lahore. All patients were right handed prior to stroke. Screening tools used will be Canadian Neurological Scale, the Mini-Mental State Examination (MMSE), the Bell Barrage test, and the ideomotor apraxia test (SpinnlerRognoni).Tests for assessment will be Fugl-Meyer test (FM) (of the upper limb), Frenchay Arm test (FAT), Box and Block test (BBT), Modified Ashworth Scale (AS) and Functional Independence Measure Motor items (FIMM). The SPSS version 21 will be used for analyzing data. The descriptive data will be expressed in Frequency and Percentages, while within the group differences will be measured by Mixed Model Anova.

Eligibility criteria: Inclusion Criteria:

* First-ever stroke,
* Enrolled 6 months after the event onset with ischemia or primary hemorrhage.
* All patients were right handed prior to stroke.

Exclusion Criteria:

* Posterior circulation infarction,
* Subarachnoid hemorrhage,
* Severe forms of neglect and anosognosia (number of errors in Bell Barrage test≥15)
* Impaired comprehension (Token test score ≤ 17)
* History of endogenous depression or serious psychiatric disorders, and
* Severe visual deficits (restricting the access to visual stimuli).

Primary outcomes:
measure: Fugl-Meyer Assessment (FMA):
timeFrame: 2 months
measure: Box and Block Test (BBT)
timeFrame: 2 months
measure: Frenchay Arm Test (FAT):
timeFrame: 2months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah IU
Study officials:
affiliation: Riphah International University
name: Maryam Shabbir, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee D, Roh H, Park J, Lee S, Han S. Drinking behavior training for stroke patients using action observation and practice of upper limb function. J Phys Ther Sci. 2013 May;25(5):611-4. doi: 10.1589/jpts.25.611. Epub 2013 Jun 29.
citation: Sugg K, Muller S, Winstein C, Hathorn D, Dempsey A. Does Action Observation Training With Immediate Physical Practice Improve Hemiparetic Upper-Limb Function in Chronic Stroke? Neurorehabil Neural Repair. 2015 Oct;29(9):807-17. doi: 10.1177/1545968314565512. Epub 2015 Jan 22.
citation: Franceschini M, Agosti M, Cantagallo A, Sale P, Mancuso M, Buccino G. Mirror neurons: action observation treatment as a tool in stroke rehabilitation. Eur J Phys Rehabil Med. 2010 Dec;46(4):517-23. Epub 2010 Apr 23.
citation: Sale P, Franceschini M. Action observation and mirror neuron network: a tool for motor stroke rehabilitation. Eur J Phys Rehabil Med. 2012 Jun;48(2):313-8. Epub 2012 Apr 20.
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: Johansson BB. Current trends in stroke rehabilitation. A review with focus on brain plasticity. Acta Neurol Scand. 2011 Mar;123(3):147-59. doi: 10.1111/j.1600-0404.2010.01417.x. Epub 2010 Aug 19.
citation: Garrison KA, Winstein CJ, Aziz-Zadeh L. The mirror neuron system: a neural substrate for methods in stroke rehabilitation. Neurorehabil Neural Repair. 2010 Jun;24(5):404-12. doi: 10.1177/1545968309354536. Epub 2010 Mar 5.
citation: Han C, Wang Q, Meng PP, Qi MZ. Effects of intensity of arm training on hemiplegic upper extremity motor recovery in stroke patients: a randomized controlled trial. Clin Rehabil. 2013 Jan;27(1):75-81. doi: 10.1177/0269215512447223. Epub 2012 Jul 16.
citation: Eng K, Siekierka E, Pyk P, Chevrier E, Hauser Y, Cameirao M, Holper L, Hagni K, Zimmerli L, Duff A, Schuster C, Bassetti C, Verschure P, Kiper D. Interactive visuo-motor therapy system for stroke rehabilitation. Med Biol Eng Comput. 2007 Sep;45(9):901-7. doi: 10.1007/s11517-007-0239-1. Epub 2007 Aug 9.
citation: Ertelt D, Small S, Solodkin A, Dettmers C, McNamara A, Binkofski F, Buccino G. Action observation has a positive impact on rehabilitation of motor deficits after stroke. Neuroimage. 2007;36 Suppl 2:T164-73. doi: 10.1016/j.neuroimage.2007.03.043. Epub 2007 Mar 31.
citation: Borges LR, Fernandes AB, Oliveira Dos Passos J, Rego IAO, Campos TF. Action observation for upper limb rehabilitation after stroke. Cochrane Database Syst Rev. 2022 Aug 5;8(8):CD011887. doi: 10.1002/14651858.CD011887.pub3.