NCT04542772

Brief Summary

In Canada, the number of stroke survivors is equivalent to the size of one of the four Atlantic Provinces. The incident rate of stroke has been increasing steadily since 1995. The majority of the stroke survivors lose upper extremity function, resulting in diminished activities of daily living (ADL). Many therapeutic interventions are recommended to improve upper extremity function or ADLs of stroke survivors, however, Mirror Therapy (MT), inexpensive intervention, can be self-administered by stroke survivors with intact cognition. Thus, the research question is whether a self-administered MT technique improves acute stroke patients' upper extremity motor function and recovery?

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

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

August 26, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

4 months

First QC Date

August 26, 2020

Last Update Submit

February 11, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Fugl-Meyer Assessment scale

    Scores of \< 31 corresponded with 'no to poor' upper extremity capacity, 32 to 47 represented 'limited capacity', 48 to 52 represented 'notable capacity' and 53 to 66 represented 'full' upper extremity capacity.

    Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks.

  • Wolf Motor Function Test

    Assess upper extremity function; maximum Score is 75; lower scores are indicative of lower functional levels.

    : Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks

Secondary Outcomes (1)

  • Modified Barthel Index

    : Assessment will be completed at 2 points: Pre-test assessment will be done within 48 hours of stroke admission and post-test assessment will be done at 4 weeks

Study Arms (2)

Mirror Therapy + Standard of Care

EXPERIMENTAL

Participants in this group will receive standard of care based on their needs along with mirror therapy education.

Other: Mirror TherapyOther: Regular Rehabilitation

Standard of Care

ACTIVE COMPARATOR

Participants in this group will receive only standard of care based on their needs.

Other: Regular Rehabilitation

Interventions

Participants will receive the standard-of-care; multidisciplinary rehabilitation intervention based on their needs and tolerance, and will receive an additional 30 min of Mirror Therapy education. During Mirror Therapy education, the patients will be educated or shown how to perform MT and the patients will complete the recommended exercises on their own for 30 minutes/day for 5 days a week/ for 4 weeks. Standard Mirror Therapy Protocol will be followed.

Mirror Therapy + Standard of Care

Participants will receive the standard-of-care, multidisciplinary rehabilitation intervention based on their needs and tolerance.

Mirror Therapy + Standard of CareStandard of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admitted with diagnosis of stroke with onset within two weeks
  • Medically stable
  • Able to follow directions
  • No severe cognitive impairments that could interfere with patient participation
  • Consent to treatment by patient
  • Alpha-Functional Independence Measure (Alpha-FIM) score of \> 40

You may not qualify if:

  • Medical instability
  • Lack of motivation
  • Recurrent/ chronic stroke
  • Recent upper extremity musculoskeletal injuries with movement restrictions
  • Receptive or global aphasia
  • Delirium
  • Unilateral neglect
  • Visual field deficiency.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Rajendran V, Jeevanantham D, Lariviere C, Singh RJ, Zeman L, Papuri P. Effectiveness of self-administered mirror therapy on upper extremity impairments and function of acute stroke patients: study protocol. Trials. 2021 Jul 9;22(1):439. doi: 10.1186/s13063-021-05380-9.

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

Central Study Contacts

Venkadesan Rajendran, PhD

CONTACT

Padma Puranam, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2020

First Posted

September 9, 2020

Study Start

May 1, 2021

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

February 15, 2021

Record last verified: 2021-02