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Effects of Action Observation Therapy on Fine Motor Skills of Upper Limb Functions in Chronic Stroke Patients.

Primary Purpose

Chronic Stroke

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Neurodevelopmental Techniques
Action observation Therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stroke

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Riphah IU

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Neurodevelopmental Techniques

Action observation Therapy

Arm Description

Conventional treatment protocol including active and active-assissted ROM exercises. (b)Proprioceptive neuro-muscular facilitation techniques. (c)Neuromuscular Developmental Techniques.

(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

Outcomes

Primary Outcome Measures

Fugl-Meyer Assessment (FMA):
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.
Box and Block Test (BBT)
Scoring The score is the number of blocks carried from one compartment to the other in one minute. Score each hand separately.
Frenchay Arm Test (FAT):
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.

Secondary Outcome Measures

Full Information

First Posted
September 25, 2020
Last Updated
March 29, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04574687
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
June 20, 2020 (Actual)
Study Completion Date
June 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurodevelopmental Techniques
Arm Type
Active Comparator
Arm Description
Conventional treatment protocol including active and active-assissted ROM exercises. (b)Proprioceptive neuro-muscular facilitation techniques. (c)Neuromuscular Developmental Techniques.
Arm Title
Action observation Therapy
Arm Type
Experimental
Arm Description
(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
Intervention Type
Other
Intervention Name(s)
Neurodevelopmental Techniques
Intervention Description
)Conventional treatment protocol including active and active-assissted ROM exercises. (b)Proprioceptive neuro-muscular facilitation techniques. (c)Neuromuscular Developmental Techniques.
Intervention Type
Other
Intervention Name(s)
Action observation Therapy
Intervention Description
(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
Primary Outcome Measure Information:
Title
Fugl-Meyer Assessment (FMA):
Description
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.
Time Frame
2 months
Title
Box and Block Test (BBT)
Description
Scoring The score is the number of blocks carried from one compartment to the other in one minute. Score each hand separately.
Time Frame
2 months
Title
Frenchay Arm Test (FAT):
Description
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.
Time Frame
2months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryam Shabbir, Phd
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah IU
City
Lahore
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24259813
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.
Results Reference
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PubMed Identifier
25613984
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.
Results Reference
background
PubMed Identifier
20414184
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.
Results Reference
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PubMed Identifier
22522432
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.
Results Reference
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PubMed Identifier
22235059
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.
Results Reference
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PubMed Identifier
20726844
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.
Results Reference
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PubMed Identifier
20207851
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.
Results Reference
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PubMed Identifier
22801472
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.
Results Reference
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PubMed Identifier
17687578
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.
Results Reference
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PubMed Identifier
17499164
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
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Effects of Action Observation Therapy on Fine Motor Skills of Upper Limb Functions in Chronic Stroke Patients.

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