NCT06027125

Brief Summary

There will be a long term effects of action observation therapy and mirror therapy on upper limb functional outcomes after subacute stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
Last Updated

November 21, 2025

Status Verified

November 1, 2025

Enrollment Period

9 months

First QC Date

August 31, 2023

Last Update Submit

November 18, 2025

Conditions

Keywords

Action observation therapy , Mirror therapy

Outcome Measures

Primary Outcomes (4)

  • Fugel Meyer assessment of upper limb

    A three-point ordinal scale is used to measure impairments of volitional movement with grades ranging from 0 (item cannot be performed) to 2 (item can be fully performed). Specific descriptions for performance accompany individual test items. Subtests exist for UE function, LE function, balance, sensation, ROM, and pain. The cumulative test score for all components is 226 with availability of specific subtest scores (e.g., UE maximum score is 66, LE score 34; balance score 14). This instrument has good construct validity and high reliability (r =0.99) for determining motor function and balance. Quantifiable outcome data allow this instrument to be accurately used for research purposes (a gold standard) and document recovery over time. The instrument requires an estimated 30 to 40 minutes to administer.

    4,5,6,7,8 week

  • Functional Independence Measure

    The FIM instrumentIncludes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition. Is an 18-item, seven-level, ordinal scale intended to be sensitive to changes over the course of a comprehensive inpatient medical rehabilitation program.

    4,5,6,7,8 week

  • Short form of the Stroke Impact Scale (SF-SIS)

    The eight items determined from the SIS 3.0 for the SF-SIS by MacIsaac et al.For this reason, we refrained from a renewed process of translation and intercultural adaptation of these eight questions. As with the SIS 2.0, the rating is based on a 5-point Likert scale (1-5 points). The raw sum score of the eight questions with a range from 8 to 40 points is converted into an interval-scaled total index of 0-100 points, the SF-SIS index. Higher scores indicate a better quality of life.

    4,5,6,7,8 week

  • Wolf motor function test

    The Wolf Motor Function Test (WMFT) quantifies upper extremity movement ability through timed single- or multiple-joint motions and functional tasks.1 The tasks are arranged in order of complexity, progress from proximal to distal joint involvement, test total extremity movement and movement speed, and require few tools and minimal training for test execution. The present study establishes the reliability and validity of the WMFT (Assessing Wolf Motor Function Test as Outcome Measure for Research in Patients After Stroke.) The original version consisted of 21 items; the widely used version of the WMFT consists of 17 items Composed of 3 parts: * Time * Functional ability * Strength

    4,5,6,7,8 week

Study Arms (2)

Action Observation Therapy group

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.

Other: Action observation Therapy

Mirror Therapy Group

EXPERIMENTAL

During the mirror therapy, the patients were seated in front of a mirror box placed at their midsagittal plane. The affected arm of the participants was placed inside the mirror box, and the unaffected arm was in front of the mirror. The patient was 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

The patients in the AOT group will be required to observe the upper limb movements or functional actions in video clips and to execute what they had observed to the best of their ability.

Action Observation Therapy group

The patients will be seated in front of a mirror box placed at their midsagittal plane to perform the movements. The affected arm of the participants was placed inside of the mirror box, and the unaffected arm was infront ofthe mirror.

Mirror Therapy Group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both male and female
  • to 6 months since unilateral stroke onset
  • Age between 40 and 70 years.
  • Baseline score of the FMA motor score between 20 and 40
  • Ability to follow the study instructions according to Montreal cognitive scale and score should be \>24.

You may not qualify if:

  • Patients with depression who will be unable to cooperate during treatment and Cardiopulmonary diseases which could hinder their ability to participate in rehabilitation
  • Visual and auditory abnormalities
  • Major medical problems or comorbidities that influenced the usage of the upper limbs or caused severe pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mid city Hospital Gujrat

Gujrat, Punjab Province, 50700, Pakistan

Location

Related Publications (13)

  • Zhu M-H, Wang J, Gu X-D, Shi M-F, Zeng M, Wang C-Y, et al. Effect of action observation therapy on daily activities and motor recovery in stroke patients. International journal of nursing sciences. 2015;2(3):279-82

    BACKGROUND
  • Bhasin A, Padma Srivastava MV, Kumaran SS, Bhatia R, Mohanty S. Neural interface of mirror therapy in chronic stroke patients: a functional magnetic resonance imaging study. Neurol India. 2012 Nov-Dec;60(6):570-6. doi: 10.4103/0028-3886.105188.

    PMID: 23287316BACKGROUND
  • Harmsen WJ, Bussmann JB, Selles RW, Hurkmans HL, Ribbers GM. A Mirror Therapy-Based Action Observation Protocol to Improve Motor Learning After Stroke. Neurorehabil Neural Repair. 2015 Jul;29(6):509-16. doi: 10.1177/1545968314558598. Epub 2014 Nov 21.

    PMID: 25416737BACKGROUND
  • Dohle C, Pullen J, Nakaten A, Kust J, Rietz C, Karbe H. Mirror therapy promotes recovery from severe hemiparesis: a randomized controlled trial. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):209-17. doi: 10.1177/1545968308324786. Epub 2008 Dec 12.

    PMID: 19074686BACKGROUND
  • Gandhi DB, Sterba A, Khatter H, Pandian JD. Mirror Therapy in Stroke Rehabilitation: Current Perspectives. Ther Clin Risk Manag. 2020 Feb 7;16:75-85. doi: 10.2147/TCRM.S206883. eCollection 2020.

    PMID: 32103968BACKGROUND
  • Buccino G. Action observation treatment: a novel tool in neurorehabilitation. Philos Trans R Soc Lond B Biol Sci. 2014 Apr 28;369(1644):20130185. doi: 10.1098/rstb.2013.0185. Print 2014.

    PMID: 24778380BACKGROUND
  • 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.

    PMID: 22235059BACKGROUND
  • Hsieh YW, Lin YH, Zhu JD, Wu CY, Lin YP, Chen CC. Treatment Effects of Upper Limb Action Observation Therapy and Mirror Therapy on Rehabilitation Outcomes after Subacute Stroke: A Pilot Study. Behav Neurol. 2020 Jan 2;2020:6250524. doi: 10.1155/2020/6250524. eCollection 2020.

    PMID: 32377266BACKGROUND
  • Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.

    PMID: 21571152BACKGROUND
  • Yavuzer G, Selles R, Sezer N, Sutbeyaz S, Bussmann JB, Koseoglu F, Atay MB, Stam HJ. Mirror therapy improves hand function in subacute stroke: a randomized controlled trial. Arch Phys Med Rehabil. 2008 Mar;89(3):393-8. doi: 10.1016/j.apmr.2007.08.162.

    PMID: 18295613BACKGROUND
  • Feigin V, Carter K, Hackett M, Barber PA, McNaughton H, Dyall L, Chen MH, Anderson C; Auckland Regional Community Stroke Study Group. Ethnic disparities in incidence of stroke subtypes: Auckland Regional Community Stroke Study, 2002-2003. Lancet Neurol. 2006 Feb;5(2):130-9. doi: 10.1016/S1474-4422(05)70325-2.

    PMID: 16426989BACKGROUND
  • Centers for Disease Control and Prevention (CDC). Prevalence of stroke--United States, 2006-2010. MMWR Morb Mortal Wkly Rep. 2012 May 25;61(20):379-82.

    PMID: 22622094BACKGROUND
  • Hewer RL. Stroke rehabilitation. Cerebral Arterial Disease Edinburgh, Scotland, Churchill Livingstone. 1976:262-80

    BACKGROUND

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 Bashir, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 7, 2023

Study Start

April 1, 2023

Primary Completion

January 1, 2024

Study Completion

February 15, 2024

Last Updated

November 21, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations