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

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.

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

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

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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