search
Back to results

Action Observation Treatment on Motor Function in Upper Limb of Patients With Chronic Stroke

Primary Purpose

Stroke

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

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, action observation treatment

Eligibility Criteria

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

Inclusion Criteria:

  • Chronic Stroke patients (with more than 6 months- 4 years) illness
  • Patients that were able to communicate and comprehend oral instructions
  • Patients with Mini Mental State Examination (MMSE) score more than 24

Exclusion Criteria:

  • Patients having psychiatric histories.
  • Visual and hearing impaired patients
  • Patients with speech impairment
  • Patients with arthritic deformities in upper limb (with or without using assistive device)
  • Patients with diagnosed mental illness.

Sites / Locations

  • Riphah international university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Action observation treatment

conventional treatment

Arm Description

Action observation treatment

conventional treatment

Outcomes

Primary Outcome Measures

modified barthal index
The Modified Barthel Index score was used for practical evaluation in activities of daily living. The MBI comprises of 10 items, 6 out of 10 items scored from 0-2 points, 2 items scored from 0-3 points and other 2 items scored from 0-3 points, giving a highest total score of 20 points.
Fugl-Meyer Assessment test
Fugl-Meyer Assessment test for Upper extermity.to assess level of motor impairment and its recovery after treatment. The FMA-UE comprises of 7 times.

Secondary Outcome Measures

Full Information

First Posted
October 7, 2021
Last Updated
October 19, 2021
Sponsor
Riphah International University
search

1. Study Identification

Unique Protocol Identification Number
NCT05084820
Brief Title
Action Observation Treatment on Motor Function in Upper Limb of Patients With Chronic Stroke
Official Title
Effects of Action Observation Treatment on Motor Function in Upper Limb of Patients With Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
July 15, 2021 (Actual)
Study Completion Date
August 15, 2021 (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
Yes

5. Study Description

Brief Summary
To determine the effects of action observation treatment on motor functions in upper limb of patients with chronic stroke
Detailed Description
Stroke is one of the major cause of death in Pakistan and also a prime source of disability in older adults.Mirror neuron system depends on motor regions, and its dominant aspect is that,it is activated for implementation of motor activity and also for its observation. This "dual activation" characteristic of mirror neuron helps in improving the observation and execution of different actions. aim of this study is to determine the effects of action observation treatment on motor function in upper limb of patients with chronic stroke. An RCT will be conducted on 14 chronic stroke patients from Omar Hospital and Riphah Rehabilitation Centre Lahore. Patients will be randomly allocated into control group (n=7) and Experimental group (n=7) by lottery method. Control group will be given only conventional treatment that included stretching, strengthening, pinching, gripping, reaching and grasping exercises, while Experimental group received conventional treatment and action observation treatment 3 days/ week for 4 weeks. Treatment outcomes will be assessed on Modified Barthel Index and Fugl-Meyer Assessment for upper extremity (FMA-UE)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, action observation treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
each participant will be requested to draw either number one or two from a box.number one refers to group A and number two refers to group B. Group A patients will receive conventional treatment of 40 minutes in total. group B is experimental group , patients will watch videos of 5 common motor tasks that implicit the usage of items to be used for action observation treatment.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Action observation treatment
Arm Type
Experimental
Arm Description
Action observation treatment
Arm Title
conventional treatment
Arm Type
Active Comparator
Arm Description
conventional treatment
Intervention Type
Combination Product
Intervention Name(s)
Action observation treatment
Intervention Description
Participants will watch 5 videos of motor tasks; each video is of 30 sec and watch for 4 times (i.e. for 2 minutes). Then patient will execute the motor act, soon after the observation with an affected limb for 2 minutes, with total rest time of 5 minutes for this treatment. Conventional treatment of muscle stretching, strengthening and ROM exercises will be given for 15 minutes including rest. Total treatment time is 40 minutes.
Intervention Type
Combination Product
Intervention Name(s)
conventional treatment
Intervention Description
conventional treatment of 40 minutes in total will be performed including Stretching (for 8-10 sec with set of 5 repetitions/ session on each side for 3 minutes total with rest), strengthening (weighted bicep curls, side arm raise and open arm movement exercises with set of 5 repetitions/ session for 9 minutes total with rest), Range of motion exercises active and passive with set of 5 repetitions/ session for 3 minutes total with rest and gripping,reaching, grasping exercises (on each side for total 25 minutes including rest) with assistance of physiotherapist
Primary Outcome Measure Information:
Title
modified barthal index
Description
The Modified Barthel Index score was used for practical evaluation in activities of daily living. The MBI comprises of 10 items, 6 out of 10 items scored from 0-2 points, 2 items scored from 0-3 points and other 2 items scored from 0-3 points, giving a highest total score of 20 points.
Time Frame
40 minutes
Title
Fugl-Meyer Assessment test
Description
Fugl-Meyer Assessment test for Upper extermity.to assess level of motor impairment and its recovery after treatment. The FMA-UE comprises of 7 times.
Time Frame
40 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic Stroke patients (with more than 6 months- 4 years) illness Patients that were able to communicate and comprehend oral instructions Patients with Mini Mental State Examination (MMSE) score more than 24 Exclusion Criteria: Patients having psychiatric histories. Visual and hearing impaired patients Patients with speech impairment Patients with arthritic deformities in upper limb (with or without using assistive device) Patients with diagnosed mental illness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zeest hashmi, MS NMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah international university
City
Islamabad
State/Province
Fedral
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32608554
Citation
Mao H, Li Y, Tang L, Chen Y, Ni J, Liu L, Shan C. Effects of mirror neuron system-based training on rehabilitation of stroke patients. Brain Behav. 2020 Aug;10(8):e01729. doi: 10.1002/brb3.1729. Epub 2020 Jul 1.
Results Reference
background
PubMed Identifier
32919473
Citation
Keller J, Stetkarova I, Macri V, Kuhn S, Petioky J, Gualeni S, Simmons capital ES, CyrillicD, Arthanat S, Zilber P. Virtual reality-based treatment for regaining upper extremity function induces cortex grey matter changes in persons with acquired brain injury. J Neuroeng Rehabil. 2020 Sep 12;17(1):127. doi: 10.1186/s12984-020-00754-7.
Results Reference
background
PubMed Identifier
31198470
Citation
Keci A, Tani K, Xhema J. Role of Rehabilitation in Neural Plasticity. Open Access Maced J Med Sci. 2019 May 14;7(9):1540-1547. doi: 10.3889/oamjms.2019.295. eCollection 2019 May 15.
Results Reference
background
PubMed Identifier
30147952
Citation
Habibi-Koolaee M, Shahmoradi L, Niakan Kalhori SR, Ghannadan H, Younesi E. Prevalence of Stroke Risk Factors and Their Distribution Based on Stroke Subtypes in Gorgan: A Retrospective Hospital-Based Study-2015-2016. Neurol Res Int. 2018 Jul 26;2018:2709654. doi: 10.1155/2018/2709654. eCollection 2018.
Results Reference
background

Learn more about this trial

Action Observation Treatment on Motor Function in Upper Limb of Patients With Chronic Stroke

We'll reach out to this number within 24 hrs