Clincosm LogoSign in Get a demo

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

Sponsor
Riphah International University (Other)
Overall Status
Completed
CT.gov ID
NCT04574687
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
9.4
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Neurodevelopmental Techniques
  • Other: Action observation Therapy
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Action Observation Therapy on Fine Motor Skills of Upper Limb Functions in Chronic Stroke Patients.
Actual Study Start Date :
Sep 15, 2019
Actual Primary Completion Date :
Jun 20, 2020
Actual Study Completion Date :
Jun 28, 2020

Arms and Interventions

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.

Other: Neurodevelopmental 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

Other: 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

Outcome Measures

Primary Outcome Measures

  1. Fugl-Meyer Assessment (FMA): [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. Box and Block Test (BBT) [2 months]

    Scoring The score is the number of blocks carried from one compartment to the other in one minute. Score each hand separately.

  3. Frenchay Arm Test (FAT): [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Riphah IU Lahore Pakistan 54000

Sponsors and Collaborators

  • Riphah International University

Investigators

  • Principal Investigator: Maryam Shabbir, Phd, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Riphah International University
ClinicalTrials.gov Identifier:
NCT04574687
Other Study ID Numbers:
  • REC/LHR//19/029 Sidra Sikander
First Posted:
Oct 5, 2020
Last Update Posted:
Mar 30, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Stroke

Study Results

No Results Posted as of Mar 30, 2021