StrokeNCT01200030
Effects of Home-based Program in Improving Sitting Balance and Upper Limb Functions in Patients With Stroke
A study testing electrical stimulation with exercises in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- electrical stimulation with exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteHong Kong
- Study dates
- Aug 2010to 31 Dec 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis with first stroke for more than 6 months
- Discharge from all rehabilitation services
- Ability to understand and follow commands
- A carer able for helping the home program
- No contraindication to assessment protocol and training
Who cannot join
- Cognitive disorder with Abbreviated Mental Test less than 7
- Unilateral neglect with Star cancellation Test less than 47
- Sensory deficit
- Unable to give informed consent
- Unable to speak either Cantonese or English or Mandarin
- Commodity that preclude them from undergoing training and assessment
- Neurological disease other than stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Home-Based Program of Transcutaneous Electrical Nerve Stimulation and Task-Related Trunk Training Improves Trunk Control in Patients With Stroke: A Randomized Controlled Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Stroke
- Being tested
- electrical stimulation with exercises, placebo stimulation with exercises
- Keywords
- Sitting balance, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical stimulation with exercisesBehavioural
electrical stimulation with exercises
placebo stimulation with exercisesBehavioural
placebo stimulation with exercises
| Study group | Role | What they receive |
|---|---|---|
| electrical stimulation with exercises | Experimental | The TENS + TRTT group received TENS simultaneously with the TRTT at home under the instruction of a physical therapist. Receives: Behavioral: electrical stimulation with exercises |
| 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. Receives: Behavioral: placebo stimulation with exercises |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 6 weeks
Secondary outcomes (1)
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.
Measured: baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionDec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shamay Ng, The Hong Kong Polytechnic University
- Investigators
- Shamay Ng, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200030
- Sponsor's protocol ID
- DHSC_NG
- Other IDs
- DHSC_NG_001
- Status last verified
- Jul 2018
- First submitted
- 10 Sep 2010
- Last updated
- 4 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Home-Based Program of Transcutaneous Electrical Nerve Stimulation and Task-Related Trunk Training Improves Trunk Control in Patients With Stroke: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01200030
- Acronym / sponsor ID
- DHSC_NG
- Conditions
- Stroke
- Keywords
- Sitting balance, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 13 Sep 2010 (estimated)
- Results
- Posted 4 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| electrical stimulation with exercises | Experimental | Behavioral: electrical stimulation with exercisesThe TENS + TRTT group received TENS simultaneously with the TRTT at home under the instruction of a physical therapist. |
| placebo stimulation with exercises | Placebo comparator | Behavioral: placebo stimulation with exercisesThe 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. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis with first stroke for more than 6 months
- Discharge from all rehabilitation services
- Ability to understand and follow commands
- A carer able for helping the home program
- No contraindication to assessment protocol and training
Key exclusion criteria (7 listed)
- Cognitive disorder with Abbreviated Mental Test less than 7
- Unilateral neglect with Star cancellation Test less than 47
- Sensory deficit
- Unable to give informed consent
- Unable to speak either Cantonese or English or Mandarin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electrical stimulation with exerciseselectrical stimulation with exercises | Behavioural | electrical stimulation with exercises |
| placebo stimulation with exercisesplacebo stimulation with exercises | Behavioural | placebo stimulation with exercises |
Primary outcome
Trunk Impairment Scale
Time frame: baseline, 6 weeks
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.
1 secondary outcome
Forward Sitting Functional Reach Test
Time frame: baseline, 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shamay Ng, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrical stimulation with exercises in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk Impairment Scale (time frame: baseline, 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.