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| ID | Type | Description | Link |
|---|---|---|---|
| DHSC_NG_001 |
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The investigators hypothesize that application of electrical stimulation would augment the effects of exercises in patients with stroke. Combined electrical stimulation with exercises for 6 weeks would lead to earlier and greater improvement in motor functions when compared with placebo-stimulation with exercises.
Previous studies have shown that repeated sensory inputs from transcutaneous electrical stimulation (TES) could enhance brain plasticity and conical motor output. Home-based rehabilitation is shown to be effective in motor recovery and improvement of functional ability in stroke rehabilitation.
The aim of this study was to develop a home-based rehabilitation program to investigate whether combined electrically induced sensory inputs through TES with task-related trunk training (TRTT) in a home-based program would induce earlier and/or greater improvement in, seated reaching distance and trunk control when compared with placebo TES and TRTT, or control with no active treatment in subjects with chronic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| electrical stimulation with exercises | Experimental | The TENS + TRTT group received TENS simultaneously with the TRTT at home under the instruction of a physical therapist. |
|
| placebo stimulation with exercises | Placebo Comparator | The TENS + TRTT group received placebo-simultaneously with the TRTT at home under the instruction of a physical therapist. |
|
| Control | No Intervention | Subjects in this group did not receive any active training. Home safety advice and health education including diet control and blood pressure monitoring were given to the subjects during the home-visit and telephone follow-up. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electrical stimulation with exercises | Behavioral | electrical stimulation with exercises |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trunk Impairment Scale | The Trunk impairment scale is a 2 to 4-point ordinal scale. The scale assesses static and dynamic sitting balance and trunk coordination. The maximum scores on the static sitting balance, dynamic sitting balance, and coordination subscales are 7, 10, and 6 points, respectively. The total score of Trunk impairment scale ranges between 0 and 23 points, with a higher score representing better trunk control. The static sitting balance subscale evaluated the trunk stability with both feet on the floor and with the legs crossed. The dynamic sitting balance subscale evaluated the ability to perform trunk side flexion. The coordination components evaluated the ability to selectively rotate the upper and lower parts of the trunk. | baseline, 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Forward Sitting Functional Reach Test | Sitting Functional Reach was used to assess the limits of stability in reaching activities. The sitting functional reach test measures how far forward, from a sitting position, a subject can bend forward to reach without losing his/her balance. A longer reaching distance indicated a better trunk control. | baseline, 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shamay Ng, PhD | The Hong Kong Polytechnic University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hong Kong Polytechnic University | Hong Kong | Hong Kong |
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| ID | Title | Description |
|---|---|---|
| FG000 | Electrical Stimulation With Exercises | electrical stimulation with exercises: electrical stimulation with exercises (TES+ TRlT) |
| FG001 | Placebo Stimulation With Exercises | placebo stimulation with exercises: placebo stimulation with exercises (pTES+ TRlT) |
| FG002 | Control | No active treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Electrical Stimulation With Exercises | electrical stimulation with exercises: electrical stimulation with exercises |
| BG001 | Placebo Stimulation With Exercises | placebo stimulation with exercises: placebo stimulation with exercises |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Trunk Impairment Scale | The Trunk impairment scale is a 2 to 4-point ordinal scale. The scale assesses static and dynamic sitting balance and trunk coordination. The maximum scores on the static sitting balance, dynamic sitting balance, and coordination subscales are 7, 10, and 6 points, respectively. The total score of Trunk impairment scale ranges between 0 and 23 points, with a higher score representing better trunk control. The static sitting balance subscale evaluated the trunk stability with both feet on the floor and with the legs crossed. The dynamic sitting balance subscale evaluated the ability to perform trunk side flexion. The coordination components evaluated the ability to selectively rotate the upper and lower parts of the trunk. | Posted | Mean | Standard Deviation | units on a scale | baseline, 6 weeks |
|
from the start of training up to 4 weeks after training ended
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Electrical Stimulation With Exercises | electrical stimulation with exercises: electrical stimulation with exercises |
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The number of home-visit in transcutaneous electrical stimulation (TES)+ task-related trunk training (TRlT) group and placebo-TES (pTES) + TRlT group was greater than the control group who had no active treatment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Shamay Ng | The Hong Kong Polytechnic University | (852) 2766-4889 | Shamay.Ng@polyu.edu.hk |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004558 | Electric Stimulation |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |
| D009043 | Motor Activity |
| D009068 | Movement |
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| placebo stimulation with exercises | Behavioral | placebo stimulation with exercises |
|
| BG002 | Control | No active treatment |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo Stimulation With Exercises | placebo stimulation with exercises: placebo stimulation with exercises |
| OG002 | Control | No active treatment |
|
|
|
| Secondary | Forward Sitting Functional Reach Test | Sitting Functional Reach was used to assess the limits of stability in reaching activities. The sitting functional reach test measures how far forward, from a sitting position, a subject can bend forward to reach without losing his/her balance. A longer reaching distance indicated a better trunk control. | Posted | Mean | Standard Deviation | cm | baseline, 6 weeks |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Placebo Stimulation With Exercises | placebo stimulation with exercises: placebo stimulation with exercises | 0 | 13 | 0 | 13 |
| EG002 | Control | No active treatment | 0 | 12 | 0 | 12 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009142 |
| Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
|