NCT04242316

Brief Summary

The aim of this study included (1) to compare the effectiveness of mirror therapy (MT) and bimanual arm training (BAT) in improving motor and functional performance of hemiplegic upper extremity for adults with chronic stroke; (2) to examine whether recruitment of the mirror neurons, as reflected in mu rhythm suppression, mediates recognition of the mirror illusion in pre/post MT, as compared to BAT without a mirror in clients with chronic stroke, as compared to healthy participants.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
101

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable stroke

Status
completed

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

Study Start

First participant enrolled

January 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

3 years

First QC Date

January 22, 2020

Last Update Submit

January 22, 2020

Conditions

Keywords

StrokeMirror therapyBilateral arm trainingUpper limb function

Outcome Measures

Primary Outcomes (3)

  • Fugl-Meyer assessment (FMA)

    FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.

    Baseline

  • Fugl-Meyer assessment (FMA)

    FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.

    After 6-week

  • Fugl-Meyer assessment (FMA)

    FMA-UE is a standard upper limb motor impairment assessment for stroke survivors. FMA-UE assesses voluntary movement, reflex activity, grasp and coordination.

    3-month after the completion of training

Secondary Outcomes (6)

  • Action Research Arm Test (ARAT)

    Baseline

  • Action Research Arm Test (ARAT)

    After 6-week

  • Action Research Arm Test (ARAT)

    3-month after the completion of training

  • Wolf Motor Function Test (WMFT)

    Baseline

  • Wolf Motor Function Test (WMFT)

    After 6-week

  • +1 more secondary outcomes

Other Outcomes (2)

  • Mu rhythm suppression generated in the sensorimotor cortex

    Baseline

  • Mu rhythm suppression generated in the sensorimotor cortex

    6-week

Study Arms (2)

Mirror Therapy

EXPERIMENTAL

Patients performed customized bimanual upper limb exercises with a mirror. They can observe the mirror visual feedback of their non-paretic hand during the movements.

Behavioral: Mirror Therapy

Bilateral arm training

ACTIVE COMPARATOR

Patients performed customized bimanual upper limb exercises without a mirror.

Behavioral: Bilateral arm training

Interventions

Mirror TherapyBEHAVIORAL

Patients performed customized bimanual upper limb exercises with graded level of difficulty based on the patient's individual levels of upper limb functioning according to the 7 levels of the FTHUE and each level consisted of 5 standardized table-top tasks. The patients practiced the movements with the unaffected hand (including the shoulder, elbow, wrist, and hand). While watching the reflection of the unaffected hand in the mirror, the patient was then asked to moving the affected hand at the same time to synchronize the movement with the reflection of the unaffected hand. If the patient was unable to move the hand, a therapist would passively assist the movement of the affected hand so as to synchronize it with the reflection of the unaffected hand.

Mirror Therapy

Patients performed customized bimanual upper limb exercises with graded level of difficulty based on the patient's individual levels of upper limb functioning according to the 7 levels of the FTHUE and each level consisted of 5 standardized table-top tasks, but without a mirror. The patients can take a direct view of their paretic hand.

Bilateral arm training

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • neurological condition with unilateral hemiparesis;
  • a Functional Test of Hemiplegic Upper Extremity (FTHUE) score between levels 2 to 6;
  • chronic stroke with onset of neurological condition more than 6 months previously;
  • ability to understand and follow simple verbal instructions;
  • ability to participate in a therapy session lasting at least 30 minutes;
  • community ambulant with or without aids.

You may not qualify if:

  • Individuals with severe neglect and severe spasticity (Modified Ashworth Scale \>3) would be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

StrokeHemiplegia

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy ModalitiesRehabilitationTherapeutics

Study Design

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

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 27, 2020

Study Start

January 1, 2014

Primary Completion

January 1, 2017

Study Completion

January 1, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share