Fractures, BoneNCT03409354
Tele-Rehabilitation Pilot Evaluation Study
A study testing Tele-rehabilitation in people with Fractures, Bone and Stroke, run by National University of Singapore at 1 site in Singapore.
Trial summary
A proof of concept randomized controlled trial (RCT) only evaluated the National University of Singapore's (NUS) T-Rehab tele-rehabilitation (TR) system at a home setting where rehabilitation was provided on an individual level. The previous RCT was also limited to stroke patients. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Fractures, Bone, Stroke, Lower Limb Joint Replacement (Hip or Knee)
- What is being tested?
- Tele-rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSingapore
- Study dates
- 15 May 2018to 30 Sep 2018
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 21 years of age
- Admitted into an inpatient or outpatient rehabilitation unit, nursing home or day care centre for an acute or chronic disability
- Deemed by any members of the multi-disciplinary rehabilitation team to potentially able to safely receive and benefit from rehabilitation post-discharge
- Cognitively able to understand and follow instructions (the Abbreviated Mental Test's score of 6 or above (out of 10).
Who cannot join
- Patients with previous seizure episodes
- Patients with limb musculoskeletal pain of at least moderate intensity (visual analogue Scale > 6 out of 10)
- Patients with pacemakers.
Trial locations and contacts
1 site in 1 country.
About this study
A proof of concept randomized controlled trial (RCT) only evaluated the National University of Singapore's (NUS) T-Rehab tele-rehabilitation (TR) system at a home setting where rehabilitation was provided on an individual level. The previous RCT was also limited to stroke patients. In addition to stroke, there are many other conditions (such as fractures, lower limb joint replacement, musculoskeletal conditions) require and benefit from rehabilitation. The primary aims of the pilot evaluation study are: (i) To document patient adherence to TR, compared to usual care (ii) To estimate the extent to which TR improves functional status, compared to usual care and (iii) To estimate the cost effectiveness of TR, compared to usual care in eight different health conditions in Singapore.
Read the detailed description
This is a 12-week quasi-experimental trial of a tele-rehabilitation program involving seven sites and up to 600 adults in Singapore.
- Conditions
- Fractures, Bone, Stroke, Lower Limb Joint Replacement (Hip or Knee), Lower Limb Amputation, Pneumonia, Fall
- Being tested
- Tele-rehabilitation, Usual care
- Medical subject headings
- Fractures, Bone, Stroke, Pneumonia, Tendinopathy, Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-rehabilitationBehavioural
There are five different categories of exercise in the rehabilitation program, which combines both physiotherapy (Category 1 to 4) and occupational therapy components (Category 5). Each tele-therapy session could cover all five categories of exercises. Progression of levels within each exercise within each category should be determined by the tele-therapist and in consultation with the participant.
Usual careBehavioural
Usual rehabilitation care (e.g., PT, OT and ST), prescribed by rehabilitation therapists at participating centers and performed by participants at participating centers.
| Study group | Role | What they receive |
|---|---|---|
| Tele-rehabilitation | Experimental | Tele-rehabilitation via iPad. Receives: Behavioral: Tele-rehabilitation |
| Usual care | Active comparator | Usual rehabilitation care, prescribed by rehabilitation therapists at participating centers and performed by participants at participating centers. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to rehabilitation over the course of a 2 week trial period
Adherence to the prescribed rehabilitation and exercise therapy will be measured over 12 weeks
Measured: At 12-weeks post-rehabilitation
Secondary outcomes (5)
EQ-5D
Perceived Health Status and Quality of Life
Measured: 12-weeks
CESD
The Center for Epidemiological Studies Depression Scale
Measured: 12-weeks
IADL
The Lawton Instrumental Activities of Daily Living (IADL) Scale
Measured: 12-weeks
Barthel Index
Barthel Index of Activities of Daily Living
Measured: 12-weeks
Health Service Utilization
Use of Health Services over the past three months
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start15 May 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fractures, BoneStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miho Asano, National University of Singapore
- Investigators
- Miho Asano, PhD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03409354
- Sponsor's protocol ID
- MHHISDRFP16217
- Status last verified
- Aug 2019
- First submitted
- 11 Jan 2018
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-Rehabilitation Pilot Evaluation Study
- ClinicalTrials.gov ID
- NCT03409354
- Acronym / sponsor ID
- MHHISDRFP16217
- Conditions
- Fractures, Bone, Stroke, Lower Limb Joint Replacement (Hip or Knee), Lower Limb Amputation, Pneumonia, Fall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 15 May 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 24 Jan 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.
A proof of concept randomized controlled trial (RCT) only evaluated the National University of Singapore's (NUS) T-Rehab tele-rehabilitation (TR) system at a home setting where rehabilitation was provided on an individual level. The previous RCT was also limited to stroke patients. In addition to stroke, there are many other conditions (such as fractures, lower limb joint replacement, musculoskeletal conditions) require and benefit from rehabilitation. The primary aims of the pilot evaluation study are: (i) To document patient adherence to TR, compared to usual care (ii) To estimate the extent to which TR improves functional status, compared to usual care and (iii) To estimate the cost effectiveness of TR, compared to usual care in eight different health conditions in Singapore.
Detailed description
This is a 12-week quasi-experimental trial of a tele-rehabilitation program involving seven sites and up to 600 adults in Singapore.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-rehabilitation | Experimental | Behavioral: Tele-rehabilitationTele-rehabilitation via iPad. |
| Usual care | Active comparator | Behavioral: Usual careUsual rehabilitation care, prescribed by rehabilitation therapists at participating centers and performed by participants at participating centers. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- at least 21 years of age
- Admitted into an inpatient or outpatient rehabilitation unit, nursing home or day care centre for an acute or chronic disability
- Deemed by any members of the multi-disciplinary rehabilitation team to potentially able to safely receive and benefit from rehabilitation post-discharge
- Cognitively able to understand and follow instructions (the Abbreviated Mental Test's score of 6 or above (out of 10).
Key exclusion criteria (3 listed)
- Patients with previous seizure episodes
- Patients with limb musculoskeletal pain of at least moderate intensity (visual analogue Scale > 6 out of 10)
- Patients with pacemakers.
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 |
|---|---|---|
| Tele-rehabilitationThere are five different categories of exercise in the rehabilitation program, which combines both physiotherapy (Category 1 to 4) and occupational therapy components (Category 5). Each tele-therapy session could cover all five categories of exercises. Progression of levels within each exercise within each category should be determined by the tele-therapist and in consultation with the participant. | Behavioural | Tele-rehabilitation |
| Usual careUsual rehabilitation care (e.g., PT, OT and ST), prescribed by rehabilitation therapists at participating centers and performed by participants at participating centers. | Behavioural | Usual care |
Primary outcome
Adherence to rehabilitation over the course of a 2 week trial period
Time frame: At 12-weeks post-rehabilitation
Adherence to the prescribed rehabilitation and exercise therapy will be measured over 12 weeks
5 secondary outcomes
EQ-5D
Time frame: 12-weeks
CESD
Time frame: 12-weeks
IADL
Time frame: 12-weeks
Barthel Index
Time frame: 12-weeks
Health Service Utilization
Time frame: 12-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 19 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Miho Asano, PhD principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-rehabilitation in people with Fractures, Bone and Stroke, run by National University of Singapore at 1 site in Singapore.
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 19 Aug 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 Singapore. 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?
Adherence to rehabilitation over the course of a 2 week trial period (time frame: At 12-weeks post-rehabilitation). 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 19 Aug 2019; AzTrials last refreshed its copy on 26 Oct 2026.