TelerehabilitationNCT04259294
The Effects of a Home-based Occupational Therapy Tele-rehabilitation for Outpatients After Hip Fracture Surgery
A study testing Caspar Telerehabilitation in people with Telerehabilitation, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
The investigators will investigate the effects of a home-based occupational therapy telerehabilitation (TR) via smartphones in enhancing functional and motor performances, and fall efficacy, for outpatients receiving day hospital rehabilitation after hip fracture surgery. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Telerehabilitation
- What is being tested?
- Caspar Telerehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2018to 31 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of hip fracture
- Post-hip surgery within 12 weeks
- Aged 60 years old or above
- Medically stable
- With Abbreviated Mental Test scored 6 or above
- Having at least one functional limitation in the basic activities of daily living assessments
Who cannot join
- The hip fracture is the result of malignancy
- There is risk of falls due to postural hypotension
- Either patients or caregiver do not understand Cantonese, English or Mandarin instructions
- They do not use a smartphone
- They are unable to read the instructions on the screen of the smartphone because of visual difficulty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of a Home-based Occupational Therapy Tele-rehabilitation Via Smartphones for Outpatients After Hip Fracture Surgery in Hong Kong: A Feasibility Randomized Controlled Study
The investigators will investigate the effects of a home-based occupational therapy telerehabilitation (TR) via smartphones in enhancing functional and motor performances, and fall efficacy, for outpatients receiving day hospital rehabilitation after hip fracture surgery.
This is a feasibility randomized controlled trial with two groups - experimental and comparison groups, involving older adults after hip fracture surgery within 12 weeks attending the Geriatric Day Hospital. Patients will be assessed at baseline, immediately post 3-weeks intervention, and follow-up after 3-weeks for motor performances, daily activities functioning and fall efficacy. The experimental group will receive home program using the use of Caspar Health e-system and a mobile app in smartphones, while the comparison group will receive paper-and-pencil instructions for the home program on weekly basis, for 3 weeks.
- Conditions
- Telerehabilitation
- Being tested
- Caspar Telerehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caspar TelerehabilitationBehavioural
The experimental group will receive home-based treatment program through mobile apps while control group will receive through a written home program sheets. The training contents will be equivalent, including trunk and lower limb strengthening and stretching, coordination, balance, and functional exercises that will be related to patients' daily living activities in their home.
The frequency and duration of the home program will be compromised by both the therapist and the patient. The videos of the home program will be sent to patients' app in smartphone by the therapist in the experimental group. Patients will perform the exercises while watching the videos in the app. After each exercise will be done, patient's performance feedback will be captured by the smartphone and will be sent back to the case therapist each time through the app while those in the control group will record their performance in a log sheet given by the therapists.
| Study group | Role | What they receive |
|---|---|---|
| Telerehabilitation group via mobile apps | Experimental | The experimental group will receive home-based treatment program through mobile apps Receives: Behavioral: Caspar Telerehabilitation |
| Control group via paper and pencil instructions | Active comparator | The control group will receive treatment via written home program sheets Receives: Behavioral: Caspar Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed up and go test (TUG)
It measures fall risk and progress in walking speed (Change from baseline at post 3-week intervention and follow-up after 3 weeks)
Measured: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
The Functional Reach Test (FR)
It measures balance (Change from baseline at post 3-week intervention and follow-up after 3 weeks)
Measured: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
Muscle strength (MS)
It will be measured using a force gauge on the strength of Quadriceps of both the affected and the non-affected legs (Change from baseline at post 3-week intervention and follow-up after 3 weeks)
Measured: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
The Pain Visual Analogue Scale (VAS)
It measures pain intensity. It consists of a 100mm horizontal line anchored with two opposite labels, i.e. labelled at the left end as 'no pain' (0mm) and at the right end as 'very severe pain' (100mm). (Change from baseline at post 3-week intervention and follow-up after 3 weeks)
Measured: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
Secondary outcomes (4)
The Hong Kong Chinese version of the Modified Barthel index (MBI)
It measures performance in basic activities of daily living. The item scores range from '0', which indicates an inability to perform, to a maximum of '5, 10 or 15', which represents total independence. The total items score of 100 indicates complete independence in self-care performance. (Change from baseline at post 3-week intervention and follow-up after 3 weeks)
Measured: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
The Hong Kong Chinese version of the Lawton Instrumental Activities of Daily Living (IADL)
It assesses nine domains of function skills (ability to use telephone, shopping, meal preparation, laundry, housekeeping, handyman work, and transportation, medication and money management) The item scores range from '0' which indicates an inability to perform, to a maximum of '2,3 or 4' which represents total independence (Change from baseline at post 3-week intervention and follow-up after 3 weeks)
Measured: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
The Fall Efficacy Scale (FES)
FES is a questionnaire to assess the level of confidence when patient perform activities of daily living without fear of fall. FES is a ten-item test rated on a 10-point scale from not confident at all to completely confident (Change from baseline at post 3-week intervention and follow-up after 3 weeks)
Measured: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
The Morse Fall Scale (MFS)
MFS predict the likelihood of falls. It consists of 6 variables: history of fall, the presence of a secondary diagnosis, the use of ambulatory aids, the administration of intravenous therapy, types of gait and mental status. MFS is rated as follows, 0: No risk for falls; <25: Low risk; 25-45: Moderate risk ; >45: High risk (Change from baseline at post 3-week intervention and follow-up after 3 weeks)
Measured: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 Jun 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelerehabilitationStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth N. K. Fong, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259294
- Sponsor's protocol ID
- HongKongPOLYU
- Status last verified
- Feb 2020
- First submitted
- 9 Jan 2020
- Last updated
- 6 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Home-based Occupational Therapy Tele-rehabilitation Via Smartphones for Outpatients After Hip Fracture Surgery in Hong Kong: A Feasibility Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04259294
- Acronym / sponsor ID
- HongKongPOLYU
- Conditions
- Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 6 Feb 2020 (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.
The investigators will investigate the effects of a home-based occupational therapy telerehabilitation (TR) via smartphones in enhancing functional and motor performances, and fall efficacy, for outpatients receiving day hospital rehabilitation after hip fracture surgery.
This is a feasibility randomized controlled trial with two groups - experimental and comparison groups, involving older adults after hip fracture surgery within 12 weeks attending the Geriatric Day Hospital. Patients will be assessed at baseline, immediately post 3-weeks intervention, and follow-up after 3-weeks for motor performances, daily activities functioning and fall efficacy. The experimental group will receive home program using the use of Caspar Health e-system and a mobile app in smartphones, while the comparison group will receive paper-and-pencil instructions for the home program on weekly basis, for 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telerehabilitation group via mobile apps | Experimental | Behavioral: Caspar TelerehabilitationThe experimental group will receive home-based treatment program through mobile apps |
| Control group via paper and pencil instructions | Active comparator | Behavioral: Caspar TelerehabilitationThe control group will receive treatment via written home program sheets |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary diagnosis of hip fracture
- Post-hip surgery within 12 weeks
- Aged 60 years old or above
- Medically stable
- With Abbreviated Mental Test scored 6 or above
Key exclusion criteria (5 listed)
- The hip fracture is the result of malignancy
- There is risk of falls due to postural hypotension
- Either patients or caregiver do not understand Cantonese, English or Mandarin instructions
- They do not use a smartphone
- They are unable to read the instructions on the screen of the smartphone because of visual difficulty
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 |
|---|---|---|
| Caspar TelerehabilitationThe experimental group will receive home-based treatment program through mobile apps while control group will receive through a written home program sheets. The training contents will be equivalent, including trunk and lower limb strengthening and stretching, coordination, balance, and functional exercises that will be related to patients' daily living activities in their home. The frequency and duration of the home program will be compromised by both the therapist and the patient. The videos of the home program will be sent to patients' app in smartphone by the therapist in the experimental group. Patients will perform the exercises while watching the videos in the app. After each exercise will be done, patient's performance feedback will be captured by the smartphone and will be sent back to the case therapist each time through the app while those in the control group will record their performance in a log sheet given by the therapists. | Behavioural | Control group via paper and pencil instructions, Telerehabilitation group via mobile apps |
Primary outcome
Timed up and go test (TUG)
Time frame: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
It measures fall risk and progress in walking speed (Change from baseline at post 3-week intervention and follow-up after 3 weeks)
The Functional Reach Test (FR)
Time frame: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
It measures balance (Change from baseline at post 3-week intervention and follow-up after 3 weeks)
Muscle strength (MS)
Time frame: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
It will be measured using a force gauge on the strength of Quadriceps of both the affected and the non-affected legs (Change from baseline at post 3-week intervention and follow-up after 3 weeks)
The Pain Visual Analogue Scale (VAS)
Time frame: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
It measures pain intensity. It consists of a 100mm horizontal line anchored with two opposite labels, i.e. labelled at the left end as 'no pain' (0mm) and at the right end as 'very severe pain' (100mm). (Change from baseline at post 3-week intervention and follow-up after 3 weeks)
4 secondary outcomes
The Hong Kong Chinese version of the Modified Barthel index (MBI)
Time frame: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
The Hong Kong Chinese version of the Lawton Instrumental Activities of Daily Living (IADL)
Time frame: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
The Fall Efficacy Scale (FES)
Time frame: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
The Morse Fall Scale (MFS)
Time frame: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)
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 6 Feb 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caspar Telerehabilitation in people with Telerehabilitation, 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 6 inclusion and 5 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 6 Feb 2020. 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?
Timed up and go test (TUG) (time frame: Measure assessing change between three time points (baseline, post 3-week intervention and follow-up after 3 weeks)). The study lists 4 primary outcomes in all. 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 6 Feb 2020.