StrokeNCT03509363
Pilot Study on Comparisons Between the Effectiveness of Mobile Video-guided and Paper-based Home Exercise Programs of Patients With Stroke Randomized Controlled Trial
A study testing Stroke physiotherapy home exercise video in people with Stroke, run by Tai Po Hospital at 1 site in Hong Kong.
Trial summary
This is a pilot study and a randomized, controlled, assessor-blinded clinical trial for patients who will complete the inpatient Stroke Rehabilitation Program in the Department of Medical and Geriatrics of Tai Po Hospital and Shatin Hospital from June 2018 to March 2019. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Stroke
- What is being tested?
- Stroke physiotherapy home exercise video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteHong Kong
- Study dates
- 23 Jul 2018to 30 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Stroke as principle diagnosis. 2. Could follow gesture and instructions of exercise training. 3. Could sit independently without back support for 2 minutes (MFAC Category II Sitter).
- 4. Discharged home without any further training in ambulatory service such as Geriatric Day Hospital (GDH) and domestic physiotherapy services.
- 5. Participants or their carers have smart devices such as smart phones or tablets that are able to scan QR code and connect to the Internet.
- 6. Participants or carers could read Chinese.
Who cannot join
- 1. Participants who could walk independently with or without walking aids (MFAC Category 6, 7) before discharge from Tai Po Hospital and Shatin Hospital medical unit.
- 2. Participants and their carers have visual or cognitive impairments that would prevent use of smart devices.
- 3. Medical condition unstable
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparisons Between the Effectiveness of Mobile Video-guided and Paper-based Home Exercise Programs on Improving Exercise Adherence, Self-Efficacy for Exercise and Functional Outcomes of Patients With Stroke a Single-blind Randomized Controlled Trial
This is a pilot study and a randomized, controlled, assessor-blinded clinical trial for patients who will complete the inpatient Stroke Rehabilitation Program in the Department of Medical and Geriatrics of Tai Po Hospital and Shatin Hospital from June 2018 to March 2019. The objective of the study is to compare the effectiveness of video-guided exercise program and standard paperbased home exercise program on adherence of exercise, self-efficacy and improving functional outcomes in patients with stroke within 3-month follow-up.
Read the detailed description
In Hong Kong, stroke patients would be referred to ambulatory services, such as geriatric day hospital, or domestic physiotherapy service to continue their stroke rehabilitation after discharge from hospital care. However, some patients could not attend ambulatory services due to vary difficulties, such as transportation and absence of carers. The low frequency of domestic physiotherapy service also reduced the effectiveness of rehabilitation of patients. Traditionally, for continuation of training at home, therapists would prescribe home exercises programs in paper-based format to stroke patients prior to discharge. However, evidence showed that written and pictorial home exercise prescription does not lead to better adherence to a home exercise programme compared to having no written and pictorial instructions for patients with stroke less than 4 months. It was suggested that the barriers to adherence of home exercise including low self-efficacy and delivery mode of training program. It is worthwhile for physiotherapists to investigate the mode of delivery to enhance exercise adherence and selfefficacy of post-discharge home exercise for patients with stroke. Recent survey concerning the development of smart technology revealed that 80% of global internet users owned a smart phone and 47% owned a tablet. Thus, the increasing accessibility of smart technology offers an opportunity to advance the mode of delivery of exercise program so as to benefit patients of stroke from increase the adherence and self-efficacy of home exercises. The evidences of using smart technology to enhance adherence of home exercise have reported inconsistent results. A study showed that home exercise programmes filmed on an electronic tablet, with an automated reminder, was not superior to standard paper-based home exercise programmes in terms of adherence, motor function, or satisfaction for patients recovering from stroke. In contrast, another study showed that people with musculoskeletal conditions adhere better to their home exercise programs when the programs are provided on an app with remote support compared to paper handouts; although the clinical importance of this added adherence is unclear. This is a pilot study and a randomized, controlled, assessor-blinded clinical trial for patients who will complete the inpatient Stroke Rehabilitation Program in the Department of Medical and Geriatrics of Tai Po Hospital and Shatin Hospital from June 2018 to March 2019. The objective of the study is to compare the effectiveness of video-guided exercise program and standard paperbased home exercise program on adherence of exercise, self-efficacy and improving functional outcomes in patients with stroke within 3-month follow-up. Eligible subjects will then be randomly assigned to either Intervention Group or Control Group in a 1:1 ratio.
Investigators who are responsible for data collection will be blinded to the group allocation. Pre-discharge training sessions last for 10- 15 minutes will be provided to patients, and their carers if any, of both groups in order to make them familiar with the selected home exercises and the technique of using mobile phone to scan QR for intervention group. Participants allocated to the intervention group will be prescribed a set of exercise video with QR code provided in home exercise pamphlets and they have to perform the prescribed exercises under the guidance of video. On the other hand, participants in control group will be given instructions for their home exercise program in a traditional pamphlet includes photographs and instructions of exercise demonstration. The content of home exercise program in both groups is the same and is based on the recommendations from the National Stroke Foundation Clinical Guidelines, including mobilization exercise, strengthening exercise and balance training which is tailor-made for different mobility level of stroke patients. Suitability of participating home exercise program will be assessed by physiotherapists based on environmental risk, fall risk and competence of patients or carers in performing exercise with patients. The number of exercises prescribed, frequency and intensity of exercise varies from participants and will be determinated by physiotherapists. Outcome measures including self-reported exercise adherence, self-efficacy for exercise, Modified Functional Ambulatory Category and Modified Barthel Index will be assessed at 1 day, 1 month and 3 month after discharged on phone follow-up basis by a blinded-assessor. We aim to recruit 28 participants in each group.
- Conditions
- Stroke
- Being tested
- Stroke physiotherapy home exercise video
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stroke physiotherapy home exercise videoBehavioural
Also called exercise video
a set of exercise video with QR code provided in home exercise pamphlets
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants allocated to the intervention group will be prescribed a set of exercise video with QR code provided in home exercise pamphlets and they have to perform the prescribed exercises under the guidance of video.The content of home exercise program in both groups is the same and is based on the recommendations from the National Stroke Foundation Clinical Guidelines, including mobilization exercise, strengthening exercise and balance training which is tailor-made for different mobility level of stroke patients. Suitability of participating home exercise program will be assessed by physiotherapists based on environmental risk, fall risk and competence of patients or carers in performing exercise with patients. The number of exercises prescribed, frequency and intensity of exercise varies from participants and will be determinated by physiotherapists Receives: Behavioral: Stroke physiotherapy home exercise video |
| Control | No intervention | Participants in control group will be given instructions for their home exercise program in a traditional pamphlet includes photographs and instructions of exercise demonstration. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese version of the Modified Barthel Index
MBI was used to assess patients' basic activities of daily living (ADL) in this study. MBI measures the participant's performance on ten functional items including self-care, continence, and locomotion.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start23 Jul 2018
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- randomized, controlled
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tai Po Hospital
- Sponsor type
- Other government
- Collaborators
- Shatin Hospital
- Responsible party
- Principal investigator, Bryan Ping Ho CHUNG, Tai Po Hospital
- Investigators
- Ping Ho CHUNG, MSc, Principal investigator, Hospital Authority, Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03509363
- Sponsor's protocol ID
- TPH-PT-001
- Status last verified
- Sep 2019
- First submitted
- 17 Apr 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons Between the Effectiveness of Mobile Video-guided and Paper-based Home Exercise Programs on Improving Exercise Adherence, Self-Efficacy for Exercise and Functional Outcomes of Patients With Stroke a Single-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03509363
- Acronym / sponsor ID
- TPH-PT-001
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Tai Po HospitalOther government
- Collaborators
- Shatin Hospital
- Study start
- 23 Jul 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 26 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study and a randomized, controlled, assessor-blinded clinical trial for patients who will complete the inpatient Stroke Rehabilitation Program in the Department of Medical and Geriatrics of Tai Po Hospital and Shatin Hospital from June 2018 to March 2019. The objective of the study is to compare the effectiveness of video-guided exercise program and standard paperbased home exercise program on adherence of exercise, self-efficacy and improving functional outcomes in patients with stroke within 3-month follow-up.
Detailed description
In Hong Kong, stroke patients would be referred to ambulatory services, such as geriatric day hospital, or domestic physiotherapy service to continue their stroke rehabilitation after discharge from hospital care. However, some patients could not attend ambulatory services due to vary difficulties, such as transportation and absence of carers. The low frequency of domestic physiotherapy service also reduced the effectiveness of rehabilitation of patients. Traditionally, for continuation of training at home, therapists would prescribe home exercises programs in paper-based format to stroke patients prior to discharge. However, evidence showed that written and pictorial home exercise prescription does not lead to better adherence to a home exercise programme compared to having no written and pictorial instructions for patients with stroke less than 4 months. It was suggested that the barriers to adherence of home exercise including low self-efficacy and delivery mode of training program. It is worthwhile for physiotherapists to investigate the mode of delivery to enhance exercise adherence and selfefficacy of post-discharge home exercise for patients with stroke. Recent survey concerning the development of smart technology revealed that 80% of global internet users owned a smart phone and 47% owned a tablet. Thus, the increasing accessibility of smart technology offers an opportunity to advance the mode of delivery of exercise program so as to benefit patients of stroke from increase the adherence and self-efficacy of home exercises. The evidences of using smart technology to enhance adherence of home exercise have reported inconsistent results. A study showed that home exercise programmes filmed on an electronic tablet, with an automated reminder, was not superior to standard paper-based home exercise programmes in terms of adherence, motor function, or satisfaction for patients recovering from stroke. In contrast, another study showed that people with musculoskeletal conditions adhere better to their home exercise programs when the programs are provided on an app with remote support compared to paper handouts; although the clinical importance of this added adherence is unclear. This is a pilot study and a randomized, controlled, assessor-blinded clinical trial for patients who will complete the inpatient Stroke Rehabilitation Program in the Department of Medical and Geriatrics of Tai Po Hospital and Shatin Hospital from June 2018 to March 2019. The objective of the study is to compare the effectiveness of video-guided exercise program and standard paperbased home exercise program on adherence of exercise, self-efficacy and improving functional outcomes in patients with stroke within 3-month follow-up. Eligible subjects will then be randomly assigned to either Intervention Group or Control Group in a 1:1 ratio.
Investigators who are responsible for data collection will be blinded to the group allocation. Pre-discharge training sessions last for 10- 15 minutes will be provided to patients, and their carers if any, of both groups in order to make them familiar with the selected home exercises and the technique of using mobile phone to scan QR for intervention group. Participants allocated to the intervention group will be prescribed a set of exercise video with QR code provided in home exercise pamphlets and they have to perform the prescribed exercises under the guidance of video. On the other hand, participants in control group will be given instructions for their home exercise program in a traditional pamphlet includes photographs and instructions of exercise demonstration. The content of home exercise program in both groups is the same and is based on the recommendations from the National Stroke Foundation Clinical Guidelines, including mobilization exercise, strengthening exercise and balance training which is tailor-made for different mobility level of stroke patients. Suitability of participating home exercise program will be assessed by physiotherapists based on environmental risk, fall risk and competence of patients or carers in performing exercise with patients. The number of exercises prescribed, frequency and intensity of exercise varies from participants and will be determinated by physiotherapists. Outcome measures including self-reported exercise adherence, self-efficacy for exercise, Modified Functional Ambulatory Category and Modified Barthel Index will be assessed at 1 day, 1 month and 3 month after discharged on phone follow-up basis by a blinded-assessor. We aim to recruit 28 participants in each group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, controlled
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Stroke physiotherapy home exercise videoParticipants allocated to the intervention group will be prescribed a set of exercise video with QR code provided in home exercise pamphlets and they have to perform the prescribed exercises under the guidance of video.The content of home exercise program in both groups is the same and is based on the recommendations from the National Stroke Foundation Clinical Guidelines, including mobilization exercise, strengthening exercise and balance training which is tailor-made for different mobility level of stroke patients. Suitability of participating home exercise program will be assessed by physiotherapists based on environmental risk, fall risk and competence of patients or carers in performing exercise with patients. The number of exercises prescribed, frequency and intensity of exercise varies from participants and will be determinated by physiotherapists |
| Control | No intervention | –Participants in control group will be given instructions for their home exercise program in a traditional pamphlet includes photographs and instructions of exercise demonstration. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Stroke as principle diagnosis. 2. Could follow gesture and instructions of exercise training. 3. Could sit independently without back support for 2 minutes (MFAC Category II Sitter).
- 4. Discharged home without any further training in ambulatory service such as Geriatric Day Hospital (GDH) and domestic physiotherapy services.
- 5. Participants or their carers have smart devices such as smart phones or tablets that are able to scan QR code and connect to the Internet.
- 6. Participants or carers could read Chinese.
Key exclusion criteria (3 listed)
- 1. Participants who could walk independently with or without walking aids (MFAC Category 6, 7) before discharge from Tai Po Hospital and Shatin Hospital medical unit.
- 2. Participants and their carers have visual or cognitive impairments that would prevent use of smart devices.
- 3. Medical condition unstable
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 |
|---|---|---|
| Stroke physiotherapy home exercise videoAlso: exercise videoa set of exercise video with QR code provided in home exercise pamphlets | Behavioural | Intervention |
Primary outcome
Chinese version of the Modified Barthel Index
Time frame: 3 months
MBI was used to assess patients' basic activities of daily living (ADL) in this study. MBI measures the participant's performance on ten functional items including self-care, continence, and locomotion.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
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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.
Ping Ho CHUNG, MSc principal investigator
Hospital Authority, Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stroke physiotherapy home exercise video in people with Stroke, run by Tai Po Hospital 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 4 inclusion and 3 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 25 Sep 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Chinese version of the Modified Barthel Index (time frame: 3 months). 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 25 Sep 2019.