NCT05544747

Brief Summary

Stroke is a medical condition which causes the cessation of blood flow to the brain cells and results in cell death and ultimately can lead to motor disorders, perception disorders, language disorders, sensory disturbances.It is well known that stroke is the leading cause of death and one of the greatest causes of long-term motor disability in adults.The incidence of stroke is increasing day by day in low-income countries as compared to high-income countries because of the effects of not using evidence-based practice in health-related conditions in low-income countries. In the last few years, several approaches have been used for the recovery of hand dexterity after stroke. Among them, the Mirror therapy, task-oriented therapy, robot-assisted rehabilitation and action observation has gained greatest attention.Action observation training is one of the new developing rehabilitation technique that targets motor learning by the activation of mirror neurons and is the most important approach that targets the motor and functional recovery in stroke patients. In action observation training, the movements are produced because of the external stimuli in which actually the visual attention recruit the cerebellar-thalamic-cortical circuit of the brain. Action observation is based on activities of the motor neuron system and they discharge mostly in association with complex tasks as compared to simple tasks.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

5 months

First QC Date

September 14, 2022

Last Update Submit

December 9, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Fugel Meyer assessment scale for upper limb

    An assessment scale for post stroke hemiplegic patients and is performance-based impairment index. This scale is having 5 domains namely Motor functioning, Sensory Functioning, Balance, Joint Range of Motion and Joint pain. I divided the motor functioning for upper extremity into 0 to 66 points and evaluates mobility, speed and coordination

    week 6

  • Box and Block Test (BBT)

    This test is used to evaluate the manual dexterity of post stroke patients. BBT is composed of wooden box with two equal compartments having 150 boxes in one compartment and patient is asked to move the boxes from one compartment to another within 60 seconds. Before starting the test an extra 15 seconds time is given to the patient for familiarization with the test. First the patient performed the activity with the healthy arm and then with the affected arm. Scoring is done on the basis of the number of boxes transferred from one compartment to another within 60 seconds

    week 6

  • Functional Independence Measure (FIM)

    The FIM is a commonly used scale for assessing the performance in basic daily activities. It contains 18 items (i.e., 13 motor and 5 cognition items), and the total score ranges from 0 to 126

    week 6

Secondary Outcomes (1)

  • Stroke Impact Scale (SIS) version 3.0

    week 6

Study Arms (2)

Action Observation Therapy

EXPERIMENTAL

The patients in the action observation therapy group will be required to observe the upper limb movements or functional actions in video clips. (i.e., the observation phase) and to execute what they had observed to the best of their ability (i.e., the execution phase). Three common categories of movements and tasks will be elected in the action observation therapy protocol based on the related literature

Other: Action Observation Therapy

Mirror Therapy

ACTIVE COMPARATOR

During the mirror therapy, the patients will be seated in front of a mirror box placed at their mid-sagittal plane. The affected arm of the participants will be placed inside the mirror box and the unaffected arm in front of the mirror. The patient will be instructed to watch the mirror reflection of the movement performed by his/her unaffected hand carefully and to imagine that the movement was performed by the affected hand.

Other: Mirror Therapy

Interventions

following phases will be included in action observation therapy group: 1. upper limb active range of motion (AROM) exercises. 2. reaching movement or object manipulation. 3. upper limb functional tasks.

Action Observation Therapy

following phases will be included in mirror therapy group: 1. AROM exercises), 2. reaching movement or object manipulation, and 3. functional task practice

Mirror Therapy

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both male and female
  • Middle cerebral artery stroke
  • to 6 months of stroke onset
  • Baseline score of the Fugyl Myer Assessment is between 20 and 60 for the upper limb.
  • Modified Ashworth scale with a score of 2 Ability to follow the study instructions-Mini mental state examination (MMSE) score \>25

You may not qualify if:

  • Participants failing to fall in this category would be excluded from the study.
  • Patients who cannot perform the active movement of the upper limb in pre-stroke condition due to musculoskeletal problems
  • cardiopulmonary diseases which could hinder their ability to participate in the rehabilitation program in this study
  • Patient with impaired cognition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helping hand institute of rehabilitation sciences

Mansehra, Pakistan

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Officials

  • Ayesha Afridi, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sania Syed, MS NMPT*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2022

First Posted

September 16, 2022

Study Start

October 1, 2022

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

December 12, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations