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Completed

NCT Number: NCT01655160

Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute Stroke

The purpose of this study will evaluate the long-term benefits, optimal dose and mechanisms of mirror therapy and its effects on physiological markers.

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Key information

Conditions

Cerebrovascular Accident Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Kwei-shan, Toayuan County, Taiwan

About this study

This trial is to examine whether (1) the immediate effects of treatment intensity in MT would occur on sensorimotor impairments and functional performance in patients with subacute stroke; (2) the long-term benefits of treatment intensity in MT on functionality can persist for six months after treatment finished; and (3) the MT could result in cortical/movement reorganization as well as the changes in physiological markers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • first episode of stroke in cortical regions
  • time since stroke less than 3 months
  • initial motor part of UE of FMA score ranging from 24 to 52
  • no serious cognitive impairment

Exclusion criteria

  • aphasia
  • visual impairments
  • major health problems or poor physical conditions
  • currently participation in any other

Treatment and study plan

MT with low-intensity group (MT-LI)

Behavioral

The MT-LI group will receive a 30-minute MT per session followed by a 30-minute functional training.

Other names: MT-LI

MT with moderate-intensity group

Behavioral

The MT-MI group will receive a 60-minute MT per session followed by a 30-minute functional training.

Other names: MT-MI

Mirror therapy with high intensity group

Behavioral

The MT-HI group will receive a 90-minute MT per session followed by a 30-minute functional training

Other names: MT-HI

Control intervention group

Behavioral

The CI group will carry out a 30-minute conventional stroke rehabilitation training per session followed by a 30-minute functional training.

Other names: CI

Primary outcomes

  1. Fugl-Meyer Assessment (FMA)

    Time frame: Baseline, change from baseline in FMA at 2 weeks, and change from baseline in FMA at 4 weeks

    The UE subscale of the FMA (max. score 66) uses a 3-point ordinal scale to assess motor impairment.

  2. Action Research Arm Test (ARAT)

    Time frame: Baseline, change of ARAT at 2 weeks, and change of ARAT at 4 weeks

    ARAT will be used to assess the motor function of UE. A total of 19 items are to test the movement of grasp, grip, pinch, and gross motor, with a scale of 0-3 for each item (maximal of 57).

  3. Motor Activity Log (MAL)

    Time frame: Baseline, change of MAL at 2 weeks, and change of MAL at 4 weeks

    The MAL is a semi-structured interview of patients to assess the amount of use (AOU) and quality of movement (QOM) of the affected upper extremity in 30 important daily activities using a 6-point ordinal scale. Higher scores indicate better performance.

  4. ABILHAND Questionnaire

    Time frame: Baseline, change of ABILHAND Questionnaire at 2 weeks, and change of ABILHAND Questionnaire at 4 weeks

    ABILHAND questionnaire is an inventory of 56 manual activities that uses a 3-point ordinal scale to measure subjectively perceived difficulty in performing everyday bimanual activity.

  5. Adelaide Activities Profile (AAP)

    Time frame: Baseline, change of AAP at 2 weeks, and change of AAP at 4 weeks

    AAP will be applied to indicate the level of participation in household and community activities. This profile includes 21 activities in the four areas: domestic chores, household maintenance, service to others, and social activities.

Secondary outcomes

  1. Functional magnetic resonance imaging (fMRI)

    Time frame: Baseline and change of fMRI at 4 weeks

    uses the blood oxygenation level-dependent (BOLD) response to evaluate the brain reorganization after intervention.

  2. Physiological marker measures

    Time frame: Baseline and change from baseline in physiological marker measures at 4 weeks

    measure inflammatory markers, oxidative stress markers, and erythrocyte deformability.

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study title

Effects and Mechanisms of Treatment Intensity of Mirror Therapy in Patients With Subacute Stroke: Outcomes in Brain and Movement Reorganization, Sensorimotor and Daily Functions, and Measures of Physiological Markers.

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Aug 1, 2012
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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