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Mirror Therapy With Cutaneous Electrical Sensory Stimulation on Lower Limb Motor Functions in Stroke

Primary Purpose

Stroke

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
MT
TENS
Lower-limb task-oriented training
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Mirror therapy, Transcutaneous Electric Nerve Stimulation, Rehabilitation

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. have had a single stroke with ischemic brain injury or intracerebral haemorrhage diagnosed by magnetic resonance imaging or computed tomography within the previous 6 to 36 months;
  2. have at least 5 degrees of active ankle dorsiflexion in the antigravity position;
  3. are able to walk 10 m independently with or without a walking aid;
  4. are able to score 6 or higher out of 10 on the abbreviated mental test;
  5. have no unilateral neglect, hemianopia or apraxia;
  6. have no skin allergy (e.g. redness or itchiness to the electrical stimulation pads) to electrical stimulation or electrodes; and
  7. are able to follow instructions and give informed consent.

Exclusion Criteria:

  1. have any additional medical, cardiovascular or orthopaedic condition that would hinder proper treatment or assessment;
  2. have visual deficits that may hinder them from benefiting from the mirror visual feedback;
  3. have receptive dysphasia; or
  4. are involved in drug studies or other clinical trials.

Sites / Locations

  • The Hong Kong Polytechnic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Placebo Comparator

Sham Comparator

Arm Label

MT + TENS

Placebo-MT+TENS

MT+placebo-TENS

control training

Arm Description

The subject will adopt a semi-seated position on a bed while the mirror board is positioned between the legs perpendicular to the subject's midline. The paretic leg will be positioned behind the mirror, with the intact leg facing the reflective surface. All subjects will be reminded to focus on the image in the mirror during MT training. All subjects will receive concurrent TENS stimulation over the common peroneal nerve while practising bilateral lower limb exercises. After 15 minutes of priming with TENS + MT, all subjects will perform 60 minutes of lower limb task-oriented training.

In the Placebo-MT+TENS group, the experimental set-up and protocol will be the same as in the MT+TENS group, except that the reflecting surface of the angle-adjustable mirror was covered with paper. After 15 minutes of priming, all subjects will perform 60 minutes of lower limb task-oriented training.

In the MT+placebo-TENS group, the experimental set-up and protocol will be the same as in the MT+TENS group. The only difference is that placebo stimulation will be applied to the paretic limb from identical-looking TENS devices with the electrical circuit disconnected inside. After 15 minutes of priming, all subjects will perform 60 minutes of lower limb task-oriented training.

All subjects will perform 60 minutes of lower limb task-oriented training only.

Outcomes

Primary Outcome Measures

The Change of Fugl-Meyer Assessment of Lower Extremity (FMA-LE)
FMA-LE is used to evaluate the lower extremity motor control, including reflexes, voluntary control of isolated movement and coordination. The scale score ranging from 0 to 34, with 17 items and ordinal scoring from 0 to 2. A higher score indicates a better lower extremity motor control. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).

Secondary Outcome Measures

The Change of Paretic ankle dorsiflexor strength
The subject's paretic ankle dorsiflexor strength (in kilograms) is measured with a Nicholas hand-held dynamometer (model 01,160, Lafayette Instrument Company, Lafayette, IN) in supine lying position. The muscle strength will be measured twice. The average strength of the 2 trials will be recorded. A higher value indicated a better paretic ankle dorsiflexor strength. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
The Change of Paretic ankle plantarflexor strength
The subject's paretic ankle plantarflexor strength (in kilograms) is measured with a Nicholas hand-held dynamometer (model 01,160, Lafayette Instrument Company, Lafayette, IN) in supine lying position. The average strength of the 2 trials will be recorded. A higher value indicated a better paretic ankle plantarflexor strength. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
The Change of 10-m walk test
10-m walk test is used to measure the walking speed in a short distance. The subject will be asked to walk 10 meter in a normal comfortable speed and maximum speed condition, respectively. The completion time will be records by stopwatch. Each condition will be repeated for 2 times. The completion time will be averaged. The shorter the completion time indicated the better performance in 10-m walk test. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
The Change of Timed 'Up and Go' test
The Time 'Up and Go' test is used to measure the Functional mobility. Each subject will be required to rise from a chair with armrests, walk 3 m forward, turn around, return to the chair and sit down. The time taken to complete this task will be measured in seconds with a stopwatch. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
The Change of Lower-extremity motor co-ordination test
The lower-extremity motor coordination test is used to measure the coordination of both the paretic and intact legs. Two red flat targets will be secured on the floor 30 cm apart. In sitting position with the feet resting flat on the floor and the heels on one of the targets, the participant will be instructed to touch 2 targets alternately with the big toe, as quickly and as accurately as possible, for 20 seconds. The number of times each target is touched will be counted. The more touch times indicated a better performance. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
The Change of Cantonese version of Community Integration Measures (CIM-C)
The level of community integration will be assessed by the Cantonese version of Community Integration Measures (CIM-C). The CIM is a client-centred questionnaire with 10 items; each item rating from 1 to 5 with a total score from 10 to 50. A higher CIM-C score indicates a higher level of community integration. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).

Full Information

First Posted
July 10, 2018
Last Updated
September 20, 2023
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT03622879
Brief Title
Mirror Therapy With Cutaneous Electrical Sensory Stimulation on Lower Limb Motor Functions in Stroke
Official Title
Effect of Mirror Therapy With Cutaneous Electrical Sensory Stimulation on Lower Limb Motor Functions in People With Stroke: A Single-blinded Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2, 2018 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to evaluate the effectiveness of concurrent mirror therapy (MT) and transcutaneous electrical nerve stimulation (TENS) in augmenting the efficacy of the lower limb task-oriented training in people with stroke. It is hypothesize that MT combined with TENS would be superior to sham-mirror therapy with TENS, or MT with placebo-TENS, or control training only in improving lower limb motor functions and walking ability in people with stroke when combined with the lower limb task-oriented training.
Detailed Description
The application of transcutaneous electrical nerve stimulation (TENS) over a paretic lower limb could augment the effects of task-oriented exercise therapy on lower limb motor function in people with stroke, possibly through increased excitability of sensorimotor cortex. In mirror therapy (MT), the intact limb performs motor tasks while its mirror reflection is superimposed over the covered paretic limb, creating a visual illusion of enhanced function over the paretic limb. The visual input during MT could substitute for reduced proprioceptive inputs and increase spatial attention of the paretic limb, which could improve motor function of the paretic limb, possibly through increased cortical activity in the lesioned hemisphere and mirror neurone system. The next question concerns whether MT could be combined with TENS and whether their synergetic effects could maximise the motor output of paretic limbs in people with stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Mirror therapy, Transcutaneous Electric Nerve Stimulation, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MT + TENS
Arm Type
Experimental
Arm Description
The subject will adopt a semi-seated position on a bed while the mirror board is positioned between the legs perpendicular to the subject's midline. The paretic leg will be positioned behind the mirror, with the intact leg facing the reflective surface. All subjects will be reminded to focus on the image in the mirror during MT training. All subjects will receive concurrent TENS stimulation over the common peroneal nerve while practising bilateral lower limb exercises. After 15 minutes of priming with TENS + MT, all subjects will perform 60 minutes of lower limb task-oriented training.
Arm Title
Placebo-MT+TENS
Arm Type
Placebo Comparator
Arm Description
In the Placebo-MT+TENS group, the experimental set-up and protocol will be the same as in the MT+TENS group, except that the reflecting surface of the angle-adjustable mirror was covered with paper. After 15 minutes of priming, all subjects will perform 60 minutes of lower limb task-oriented training.
Arm Title
MT+placebo-TENS
Arm Type
Placebo Comparator
Arm Description
In the MT+placebo-TENS group, the experimental set-up and protocol will be the same as in the MT+TENS group. The only difference is that placebo stimulation will be applied to the paretic limb from identical-looking TENS devices with the electrical circuit disconnected inside. After 15 minutes of priming, all subjects will perform 60 minutes of lower limb task-oriented training.
Arm Title
control training
Arm Type
Sham Comparator
Arm Description
All subjects will perform 60 minutes of lower limb task-oriented training only.
Intervention Type
Behavioral
Intervention Name(s)
MT
Intervention Description
A customised angle-adjustable frame with a mirror board (60 × 90 cm) will be used. All subjects are instructed to perform hip flexion/abduction, knee flexion/extension and ankle dorsiflexion/plantarflexion on the intact-limb during a 15 minutes period.
Intervention Type
Device
Intervention Name(s)
TENS
Intervention Description
TENS will be delivered to the common peroneal nerve of the paretic leg. The stimulation frequency will be 100Hz and with an intensity just below the motor threshold.
Intervention Type
Behavioral
Intervention Name(s)
Lower-limb task-oriented training
Intervention Description
The lower-limb task-oriented training comprises 6 exercises, namely stepping up and down, heel lift a dorsiflexed position, partial squatting, kicking a ball with alternate legs, gait re-education and transition training. Each exercise last for 10 minutes
Primary Outcome Measure Information:
Title
The Change of Fugl-Meyer Assessment of Lower Extremity (FMA-LE)
Description
FMA-LE is used to evaluate the lower extremity motor control, including reflexes, voluntary control of isolated movement and coordination. The scale score ranging from 0 to 34, with 17 items and ordinal scoring from 0 to 2. A higher score indicates a better lower extremity motor control. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
Time Frame
Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
Secondary Outcome Measure Information:
Title
The Change of Paretic ankle dorsiflexor strength
Description
The subject's paretic ankle dorsiflexor strength (in kilograms) is measured with a Nicholas hand-held dynamometer (model 01,160, Lafayette Instrument Company, Lafayette, IN) in supine lying position. The muscle strength will be measured twice. The average strength of the 2 trials will be recorded. A higher value indicated a better paretic ankle dorsiflexor strength. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
Time Frame
Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
Title
The Change of Paretic ankle plantarflexor strength
Description
The subject's paretic ankle plantarflexor strength (in kilograms) is measured with a Nicholas hand-held dynamometer (model 01,160, Lafayette Instrument Company, Lafayette, IN) in supine lying position. The average strength of the 2 trials will be recorded. A higher value indicated a better paretic ankle plantarflexor strength. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
Time Frame
Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
Title
The Change of 10-m walk test
Description
10-m walk test is used to measure the walking speed in a short distance. The subject will be asked to walk 10 meter in a normal comfortable speed and maximum speed condition, respectively. The completion time will be records by stopwatch. Each condition will be repeated for 2 times. The completion time will be averaged. The shorter the completion time indicated the better performance in 10-m walk test. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
Time Frame
Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
Title
The Change of Timed 'Up and Go' test
Description
The Time 'Up and Go' test is used to measure the Functional mobility. Each subject will be required to rise from a chair with armrests, walk 3 m forward, turn around, return to the chair and sit down. The time taken to complete this task will be measured in seconds with a stopwatch. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
Time Frame
Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
Title
The Change of Lower-extremity motor co-ordination test
Description
The lower-extremity motor coordination test is used to measure the coordination of both the paretic and intact legs. Two red flat targets will be secured on the floor 30 cm apart. In sitting position with the feet resting flat on the floor and the heels on one of the targets, the participant will be instructed to touch 2 targets alternately with the big toe, as quickly and as accurately as possible, for 20 seconds. The number of times each target is touched will be counted. The more touch times indicated a better performance. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
Time Frame
Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)
Title
The Change of Cantonese version of Community Integration Measures (CIM-C)
Description
The level of community integration will be assessed by the Cantonese version of Community Integration Measures (CIM-C). The CIM is a client-centred questionnaire with 10 items; each item rating from 1 to 5 with a total score from 10 to 50. A higher CIM-C score indicates a higher level of community integration. The assessment will be conducted at baseline, mid-intervention (4 weeks), post-intervention (8 weeks) and 3-month follow-up (20 weeks).
Time Frame
Baseline (0 week), Mid-intervention (4 weeks), Post-intervention (8 weeks), 3-month follow-up (20 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: have had a single stroke with ischemic brain injury or intracerebral haemorrhage diagnosed by magnetic resonance imaging or computed tomography within the previous 6 to 36 months; have at least 5 degrees of active ankle dorsiflexion in the antigravity position; are able to walk 10 m independently with or without a walking aid; are able to score 6 or higher out of 10 on the abbreviated mental test; have no unilateral neglect, hemianopia or apraxia; have no skin allergy (e.g. redness or itchiness to the electrical stimulation pads) to electrical stimulation or electrodes; and are able to follow instructions and give informed consent. Exclusion Criteria: have any additional medical, cardiovascular or orthopaedic condition that would hinder proper treatment or assessment; have visual deficits that may hinder them from benefiting from the mirror visual feedback; have receptive dysphasia; or are involved in drug studies or other clinical trials.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SSM Ng, PhD
Phone
+852 2766-4889
Email
shamay.ng@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SSM Ng, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SSM Ng, PhD
Phone
27664889
Email
Shamay.Ng@polyu.edu.hk
First Name & Middle Initial & Last Name & Degree
SSM Ng, PhD

12. IPD Sharing Statement

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Mirror Therapy With Cutaneous Electrical Sensory Stimulation on Lower Limb Motor Functions in Stroke

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