- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04574687
Effects of Action Observation Therapy on Fine Motor Skills of Upper Limb Functions in Chronic Stroke Patients.
March 29, 2021 updated by: Riphah International University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lahore, Pakistan, 54000
- Riphah IU
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Neurodevelopmental Techniques
Conventional treatment protocol including active and active-assissted ROM exercises.
(b)Proprioceptive neuro-muscular facilitation techniques.
(c)Neuromuscular Developmental Techniques.
|
)Conventional treatment protocol including active and active-assissted ROM exercises.
(b)Proprioceptive neuro-muscular facilitation techniques.
(c)Neuromuscular Developmental Techniques.
|
|
Experimental: Action observation Therapy
(a) active range of motion (AROM) exercises (10 min), (b) reaching movement or object manipulation (10 min), and (c) UE functional tasks (15 min).
+ Conventional treatment protocol as in group A
|
(a) active range of motion (AROM) exercises (10 min), (b) reaching movement or object manipulation (10 min), and (c) UE functional tasks (15 min).
+ Conventional treatment protocol as in group A
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl-Meyer Assessment (FMA):
Time Frame: 2 months
|
Scoring.
The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item.
A zero score is given for the item if the subject cannot do the task.
A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully.
|
2 months
|
|
Box and Block Test (BBT)
Time Frame: 2 months
|
Scoring The score is the number of blocks carried from one compartment to the other in one minute.
Score each hand separately.
|
2 months
|
|
Frenchay Arm Test (FAT):
Time Frame: 2months
|
The Frenchay Arm Test (FAT) is devised for measuring the motor control in proximal joints and dexterity of the upper limb during ADL performance in patients with impairments caused by neurological conditions.Scoring and Score Interpretation Each item is scored as either pass (=1) or fail (=0).
Total scores range from 0 to 5.
|
2months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2019
Primary Completion (Actual)
June 20, 2020
Study Completion (Actual)
June 28, 2020
Study Registration Dates
First Submitted
September 25, 2020
First Submitted That Met QC Criteria
October 1, 2020
First Posted (Actual)
October 5, 2020
Study Record Updates
Last Update Posted (Actual)
March 30, 2021
Last Update Submitted That Met QC Criteria
March 29, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/LHR//19/029 Sidra Sikander
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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