Mobility LimitationNCT06245135
TIME™ at Home Randomized Controlled Trial
A study testing TIME at Home in people with Mobility Limitation, run by University of Toronto at 4 sites in Canada.
Trial summary
The goal of this randomized controlled trial is to compare the short-term effects of a virtual, community-based, task-oriented group exercise program (TIME™ at Home) with a waitlist control in community-dwelling adults with balance and mobility limitations. The main questions the trial aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mobility Limitation
- What is being tested?
- TIME at Home
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesCanada
- Study dates
- 19 Jul 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult defined as age 18 years or older;
- mobility limitations (eg, need to use a walking aid, difficulty stepping onto curbs, ramps, stairs, or walk on uneven surfaces);
- living independently in the community (in own home or assisted living settings);
- able to walk a minimum of 10 metres independently (with walking aids if used) without assistance and/or supervision from another person;
- able to stand up from and sit down onto a chair independently, without supervision;
- able to maintain balance while exercising in standing (e.g., marching on the spot) holding onto the back of a chair or a sturdy countertop;
Show all 10Show fewer
- has a study partner (e.g., caregiver, family member or friend) willing to be present, at minimum, during the first evaluation in the home via Zoom;
- able to speak and read English to understand informed consent and follow instructions for study procedures and exercises;
- caregiver defined as an individual who helps the exercise participant to live at home by providing support and assistance with at least one basic (e.g., self-care) and/or instrumental activity of daily living (e.g., doing groceries, cleaning, managing finances, making meals, doing laundry, etc.) at least once a week;
- able to speak and read English.
Who cannot join
- involvement in another formal exercise or rehabilitation program in the next 2 months;
- previous participation in the TIME at Home exercise program;
- health conditions or symptoms preventing participation in exercise;
- cognitive impairment, defined as a score of <11/15 on the 5-minute Montreal Cognitive Assessment (MoCA);
- severe visual impairment;
- severe hearing impairment
- Caregivers
- 1. Is a paid personal support worker.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2G5
Doyeon Hwang, MScPH, (825) 975-4800, rehab.timestudy@ualberta.ca
- Recruiting
Bruyère Research Institute
Ottawa, Ontario, K1N 5C8
Asefeh Memarian, MSc, (613) 562-6262 ext. 1419, amemarian@bruyere.org
- Recruiting
University of Toronto
Toronto, Ontario, M5G 1V7
Renato Barbosa dos Santos, MSc, (416) 946-7579, timestudy@utoronto.ca
Nancy Salbach, PhD
- Recruiting
University of Manitoba
Winnipeg, Manitoba, R3E 0T6
Roheema Ewesesan, MD, (204) 787-8015, Roheema.Ewesesan@umanitoba.ca
About this study
Official title: Short-term Effects of a Virtual, Community-based, Task-oriented Group Exercise Program Compared to a Waitlist Control in Increasing Function Among Adults With Balance and Mobility Limitations: The TIME™ at Home Randomized Controlled Trial
The goal of this randomized controlled trial is to compare the short-term effects of a virtual, community-based, task-oriented group exercise program (TIME™ at Home) with a waitlist control in community-dwelling adults with balance and mobility limitations.
The main questions the trial aims to answer are:
Read more
- Will there be improvements in physical and mental health outcomes, and caregiver mood and assistance, following participation in the TIME™ at Home exercise program that are greater than in the waitlist control group?
- Will level of mobility limitation, sex, or gender influence the experiences of people in the exercise program?
- What will be the costs of the TIME™ at Home exercise program for the organization delivering the program, and the people who are in the exercise program?
Participants and their caregivers will be asked to complete 3 evaluations using Zoom at study entry and 2 and 5 months later.
- Participants will complete tests of balance and walking and questionnaires.
- Caregivers will only complete questionnaires.
After the first evaluation, participants will be randomly assigned to either participate in:
- the 8-week TIME™ at Home exercise program from their homes using Zoom, or
- to wait 5 months (waitlist control group) before beginning the 8-week TIME™ at Home exercise program
Read the detailed description
Mobility limitations are highly prevalent, limit everyday functioning, and increase the need for caregiver assistance in people with chronic health conditions, such as stroke, and multiple sclerosis. While community exercise programs have been shown to improve physical and mental health, older adults with mobility limitations face numerous challenges with attending in-person community exercise programs. Challenges relate to the availability and cost of transportation, inclement weather, inadequate building access, program cost, risk of infection, and pandemic-related program closures. In addition, caregivers commonly need to provide transportation, which can take time away from paid employment and other daily activities. Some recreation centres do not have the funding to operate exercise programs for people with balance and mobility limitations that require instructors with specialized skills and a high level of exercise supervision.
The objectives of the TIME™ at Home randomized controlled trial are:
- To estimate the short-term effects of a virtual, community-based, task-oriented group exercise program (TIME™ at Home) compared to a waitlist control on improving everyday function (primary outcome), mobility, well-being, reliance on walking aids, caregiver assistance, caregiver mood, and caregiver confidence in care-recipient balance (secondary outcomes) in community-dwelling adults with mobility limitations;
- To determine whether level of mobility limitation, sex, or gender, modifies the effect of the TIME™ at Home program compared to a waitlist control in improving everyday function;
- To assess the cost-effectiveness of the TIME™ at Home program from a societal perspective; and
- To explore exercise participants', caregivers' and program providers' experiences during the intervention phase.
- Conditions
- Mobility Limitation
- Being tested
- TIME at Home
- Keywords
- Virtual Exercise, Community-based Exercise, Mobility, Balance, Randomized Controlled Trial
- Medical subject headings
- Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIME at HomeBehavioural
Sessions involve a 15-minute pre-video safety check and social time; streaming a 1-hour pre-recorded exercise video; and a 15-minute post-video social time. Two trained facilitators run each class, with a maximum group size of 10 people.
The 1-hour exercise videos include a seated warm-up and cooldown, and 40 minutes of functional, self-paced exercises. In the video, 2 healthcare professionals demonstrate a lower and higher difficulty level of each exercise. The program starts with a level 1 video and switches to a level 2 video midway.
A registered healthcare professional, called the healthcare partner, visits select classes and serves as a resource to participants and facilitators.
| Study group | Role | What they receive |
|---|---|---|
| TIME at Home | Experimental | TIME at Home is a virtual, group, task-oriented exercise program targeting balance and mobility. A community organization delivers two 1.5-hour sessions per week, for 8 weeks using Zoom. Receives: Behavioral: TIME at Home |
| Waitlist | No intervention | Individuals in the waitlist control group will receive the TIME at Home program following the final 5-month evaluation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Subjective Index of Physical and Social Outcome-Physical scale (SIPSO-P) from baseline to 2 months
Score from 0 to 20 points, 5-item self-report scale measuring everyday functioning
Measured: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Secondary outcomes (17)
7-item Berg balance scale (7BBS)
Score from 0 to 28 points on 7-item performance-based measure
Measured: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
30-second sit-to-stand test (30STS)
Number of stands completed in 30 seconds
Measured: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Timed 'up and go' (TUG) test
Time in seconds, taken to stand up from a standard armchair, walk a distance of 3 metres, turn around, walk back to the chair, and sit down again
Measured: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
3-metre walk test (3mWT, comfortable pace)
Comfortable walking speed in metres/second based on time taken to walk 3 metres
Measured: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
3-metre walk test (3mWT, fast pace)
Fast walking speed in metres/second based on time taken to walk 3 metres
Measured: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
2-minute step test (2ST)
Number of times the knee reaches the required height in 2 minutes
Measured: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Activities-specific balance confidence (ABC) scale
Score from 0 to 100 points on the 16-item self-report scale
Measured: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Center for epidemiological studies depression (CES-D) scale
Score from 0 to 60 points on the 20-item self-report scale
Measured: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
PROMIS v2.0 Social Isolation short form
Score from 0 to 20 points on the 4-item self-report scale
Measured: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
EuroQoL-5D-5L visual analog scale (EQ-VAS)
Score from 0 to 100 points on the visual analog scale
Measured: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Caregiver Assistance Scale (CAS)
Score from 0 to 102 points on the 17-item self-report scale, completed by caregiver
Measured: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Center for epidemiological studies depression (CES-D) scale-Caregiver
Score from 0 to 60 points on the 20-item self-report scale, completed by caregiver
Measured: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Activities-specific balance confidence (ABC) scale-Caregiver
Score from 0 to 100 points on the 16-item self-report scale, completed by caregiver
Measured: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Program delivery cost
Cost ($) for community organizations to run the TIME at Home program in the Experimental group
Measured: 2 months (immediately post-intervention)
Cost ($) of exercise participation
Cost ($) for a participant in the Experimental group to participate in the TIME at Home program
Measured: 2 months (immediately post-intervention)
Amount ($) willing to pay to register for TIME at Home
Amount ($) that participants in the Experimental group would be willing to pay out-of-pocket to receive the program
Measured: 2 months (immediately post-intervention)
Quality-adjusted life-years (QALYs)
Scores on the EQ-5D-5L convert to a single index value used to calculate quality-adjusted life-years (QALYs)
Measured: 2 months (immediately post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start19 Jul 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mobility LimitationStudies 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
- Parallel assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto, March of Dimes, Canada, Heart and Stroke Foundation of Canada, University of Alberta, University of Manitoba, Bruyère Health Research Institute.
- Responsible party
- Principal investigator, Dr. Nancy Salbach, University of Toronto
- Investigators
- Nancy Salbach, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245135
- Sponsor's protocol ID
- 45343
- Status last verified
- Dec 2024
- First submitted
- 29 Jan 2024
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The anonymized data collected during the study, the trial protocol, statistical analysis plan, and informed consent form, will be shared with qualified researchers engaging in REB-approved independent scientific research, upon request to the research team.
Publications
Salbach NM, Jones CA, Barclay R, Sveistrup H, Sheehy L, Bayley MT, Inness EL, Legasto-Mulvale JM, Barbosa Dos Santos R, Fung J, Moineddin R, Teasell RW, Catizzone M, Hovanec N, Cameron JI, Munce S, O'Neil J, Jaglal SB, Aravind G, Su TT, Hanson HM. Short-term effects of a virtual, community-based, task-oriented group exercise programme incorporating a healthcare-community partnership compared to a waitlist control on increasing everyday function among adults with mobility limitations: protocol for the TIME at Home randomised controlled trial. BMJ Open. 2025 Jul 28;15(7):e102694. doi: 10.1136/bmjopen-2025-102694.
PubMed 40721264
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of a Virtual, Community-based, Task-oriented Group Exercise Program Compared to a Waitlist Control in Increasing Function Among Adults With Balance and Mobility Limitations: The TIME™ at Home Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06245135
- Acronym / sponsor ID
- 45343
- Conditions
- Mobility Limitation
- Keywords
- Virtual Exercise, Community-based Exercise, Mobility, Balance, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- University Health Network, Toronto, March of Dimes, Canada, Heart and Stroke Foundation of Canada, University of Alberta, University of Manitoba, Bruyère Health Research Institute.
- Study start
- 19 Jul 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 7 Feb 2024 (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 goal of this randomized controlled trial is to compare the short-term effects of a virtual, community-based, task-oriented group exercise program (TIME™ at Home) with a waitlist control in community-dwelling adults with balance and mobility limitations.
The main questions the trial aims to answer are:
- Will there be improvements in physical and mental health outcomes, and caregiver mood and assistance, following participation in the TIME™ at Home exercise program that are greater than in the waitlist control group?
- Will level of mobility limitation, sex, or gender influence the experiences of people in the exercise program?
- What will be the costs of the TIME™ at Home exercise program for the organization delivering the program, and the people who are in the exercise program?
Participants and their caregivers will be asked to complete 3 evaluations using Zoom at study entry and 2 and 5 months later.
- Participants will complete tests of balance and walking and questionnaires.
- Caregivers will only complete questionnaires.
After the first evaluation, participants will be randomly assigned to either participate in:
- the 8-week TIME™ at Home exercise program from their homes using Zoom, or
- to wait 5 months (waitlist control group) before beginning the 8-week TIME™ at Home exercise program
Detailed description
Mobility limitations are highly prevalent, limit everyday functioning, and increase the need for caregiver assistance in people with chronic health conditions, such as stroke, and multiple sclerosis. While community exercise programs have been shown to improve physical and mental health, older adults with mobility limitations face numerous challenges with attending in-person community exercise programs. Challenges relate to the availability and cost of transportation, inclement weather, inadequate building access, program cost, risk of infection, and pandemic-related program closures. In addition, caregivers commonly need to provide transportation, which can take time away from paid employment and other daily activities. Some recreation centres do not have the funding to operate exercise programs for people with balance and mobility limitations that require instructors with specialized skills and a high level of exercise supervision.
The objectives of the TIME™ at Home randomized controlled trial are:
- To estimate the short-term effects of a virtual, community-based, task-oriented group exercise program (TIME™ at Home) compared to a waitlist control on improving everyday function (primary outcome), mobility, well-being, reliance on walking aids, caregiver assistance, caregiver mood, and caregiver confidence in care-recipient balance (secondary outcomes) in community-dwelling adults with mobility limitations;
- To determine whether level of mobility limitation, sex, or gender, modifies the effect of the TIME™ at Home program compared to a waitlist control in improving everyday function;
- To assess the cost-effectiveness of the TIME™ at Home program from a societal perspective; and
- To explore exercise participants', caregivers' and program providers' experiences during the intervention phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment
| Arm | Type | Receives |
|---|---|---|
| TIME at Home | Experimental | Behavioral: TIME at HomeTIME at Home is a virtual, group, task-oriented exercise program targeting balance and mobility. A community organization delivers two 1.5-hour sessions per week, for 8 weeks using Zoom. |
| Waitlist | No intervention | –Individuals in the waitlist control group will receive the TIME at Home program following the final 5-month evaluation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- adult defined as age 18 years or older;
- mobility limitations (eg, need to use a walking aid, difficulty stepping onto curbs, ramps, stairs, or walk on uneven surfaces);
- living independently in the community (in own home or assisted living settings);
- able to walk a minimum of 10 metres independently (with walking aids if used) without assistance and/or supervision from another person;
- able to stand up from and sit down onto a chair independently, without supervision;
Key exclusion criteria (8 listed)
- involvement in another formal exercise or rehabilitation program in the next 2 months;
- previous participation in the TIME at Home exercise program;
- health conditions or symptoms preventing participation in exercise;
- cognitive impairment, defined as a score of <11/15 on the 5-minute Montreal Cognitive Assessment (MoCA);
- severe visual impairment;
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 |
|---|---|---|
| TIME at HomeSessions involve a 15-minute pre-video safety check and social time; streaming a 1-hour pre-recorded exercise video; and a 15-minute post-video social time. Two trained facilitators run each class, with a maximum group size of 10 people. The 1-hour exercise videos include a seated warm-up and cooldown, and 40 minutes of functional, self-paced exercises. In the video, 2 healthcare professionals demonstrate a lower and higher difficulty level of each exercise. The program starts with a level 1 video and switches to a level 2 video midway. A registered healthcare professional, called the healthcare partner, visits select classes and serves as a resource to participants and facilitators. | Behavioural | TIME at Home |
Primary outcome
Change in Subjective Index of Physical and Social Outcome-Physical scale (SIPSO-P) from baseline to 2 months
Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Score from 0 to 20 points, 5-item self-report scale measuring everyday functioning
17 secondary outcomes
7-item Berg balance scale (7BBS)
Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
30-second sit-to-stand test (30STS)
Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Timed 'up and go' (TUG) test
Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
3-metre walk test (3mWT, comfortable pace)
Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
3-metre walk test (3mWT, fast pace)
Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
2-minute step test (2ST)
Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Activities-specific balance confidence (ABC) scale
Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Center for epidemiological studies depression (CES-D) scale
Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
PROMIS v2.0 Social Isolation short form
Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
EuroQoL-5D-5L visual analog scale (EQ-VAS)
Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Caregiver Assistance Scale (CAS)
Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Center for epidemiological studies depression (CES-D) scale-Caregiver
Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Activities-specific balance confidence (ABC) scale-Caregiver
Time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)
Program delivery cost
Time frame: 2 months (immediately post-intervention)
Cost ($) of exercise participation
Time frame: 2 months (immediately post-intervention)
Amount ($) willing to pay to register for TIME at Home
Time frame: 2 months (immediately post-intervention)
Quality-adjusted life-years (QALYs)
Time frame: 2 months (immediately post-intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Derived from this study: PubMed 40721264Salbach NM, Jones CA, Barclay R, Sveistrup H, Sheehy L, Bayley MT, Inness EL, Legasto-Mulvale JM, Barbosa Dos Santos R, Fung J, Moineddin R, Teasell RW, Catizzone M, Hovanec N, Cameron JI, Munce S, O'Neil J, Jaglal SB, Aravind G, Su TT, Hanson HM. Short-term effects of a virtual, community-based, task-oriented group exercise programme incorporating a healthcare-community partnership compared to a waitlist control on increasing everyday function among adults with mobility limitations: protocol for the TIME at Home randomised controlled trial. BMJ Open. 2025 Jul 28;15(7):e102694. doi: 10.1136/bmjopen-2025-102694.
- Individual participant dataSharing planned: Yes. The anonymized data collected during the study, the trial protocol, statistical analysis plan, and informed consent form, will be shared with qualified researchers engaging in REB-approved independent scientific research, upon request to the research team.
Related trials for Mobility Limitation
Not yet recruiting
Supplementary Neuromuscular Rehabilitation During Acute Concussion Recovery
Concussion (Diagnosis), Gait Abnormality
Active, not recruiting
Comparative Effects of Cyriax Approach With and Without Mobilization With Movement in Shoulder Restriction With Rotator Cuff Tendinopathy
Rotator Cuff Tendinopathy
Not yet recruiting
Effects of Low-Load Blood Flow Restriction Resistance Training With and Without Hip Abductor Strengthening in Patients With Knee Osteoarthritis.(BFR)
Knee Osteoarthritis
Active, not recruiting
Effects of Blood Flow Restriction Training and Instrument-Assisted Soft Tissue Mobilization for Pain, Strength, Range of Motion, and Kinesiophobia Among ACL Reconstruction Patients.
ACL Reconstruction
Active, not recruiting
Randomized Clinical Trial to Improve Mobility After Hospitalization
Hypertension, Diabetes
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.
Nancy Salbach, PhD principal investigator
University of Toronto
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIME at Home in people with Mobility Limitation, run by University of Toronto at 4 sites in Canada.
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 10 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renato Barbosa dos Santos, MSc (416-946-7579, timestudy@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Subjective Index of Physical and Social Outcome-Physical scale (SIPSO-P) from baseline to 2 months (time frame: 0 months (baseline), 2 months (immediately post-intervention), and 5 months (3 months post-intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06245135, which also lists 1 linked publication.
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 30 Dec 2024.