Tele-rehabilitation and radiation for patients with gliomas
| ISRCTN | ISRCTN37366438 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37366438 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 24-5893 |
| Sponsor | University Health Network |
| Funders | University Health Network Foundation, Princess Margaret Cancer Foundation |
- Submission date
- 06/11/2025
- Registration date
- 07/11/2025
- Last edited
- 11/11/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Primary brain tumours (or tumours that start in the brain) are becoming more common and can lead to serious long-term challenges such as difficulty walking, thinking and talking. Treatments like radiation therapy can help people live longer, but often with significant changes to how they function. Rehabilitation can help improve these changes and enhance the quality of life of people living with primary brain tumours; however, it is almost always in-person and starts after radiation therapy, when many difficulties have already set in.
This study proposes to start rehabilitation at the same time as radiation therapy and deliver it through telerehabilitation. This is therapy provided through video calls and other communication technologies. Telerehabilitation is an effective way to provide therapy to patients with brain tumours at home; however, little is known about how feasible, safe or beneficial it is when started at the same time as radiation therapy.
The goal of this study is to understand if it is feasible for adults who have been recently diagnosed with a primary brain tumour to participate in telerehabilitation during their radiation therapy. It aims to answer whether 1) it is safe and beneficial to deliver an 8-week telerehabilitation program while a person is also receiving radiation therapy; 2) what questionnaires and physical and cognitive tests are feasible for participants to complete, and how often; and 3) what are the experiences of participants with their telerehabilitation.
Who can participate?
Adults 18 years of age or older who have been diagnosed with a primary brain tumour of any grade, and are planning to start their first course of radiation therapy. Participants must also have had brain surgery within the past 12 weeks and have a support person available to provide physical assistance during the study.
What does the study involve?
Participants will be randomly assigned to one of two groups for 8 weeks, starting at the same time as their radiation therapy:
• Active Care Group: Participants will receive telerehabilitation from a physiotherapist, occupational therapist, and/or speech-language pathologist twice a week for up to 8 weeks.
• Usual Care Group: Participants will receive a home exercise program to help build strength and fitness, along with access to BrainHQ, an online program designed to improve thinking and memory.
All participants will complete questionnaires and tests of their physical and thinking abilities every 4 weeks for 12 weeks (a total of 4 times), and again at 26 weeks. At the end of the study, those in the Active Care group will be invited to share their experiences about telerehabilitation in a one-on-one interview.
What are the possible benefits and risks of participating?
Possible benefits: People participating in this study may receive rehabilitation earlier in their disease course, which could help improve their function sooner. Therapy is delivered remotely, so participants can do it from the comfort of their home. Those in the Usual Care group will receive physical and thinking exercises that they can do on their own.
Possible risks: Physical exercise can sometimes lead to muscle soreness, fatigue, falls or injury. In rare cases, it may also lead to heart problems, such chest discomfort or an irregular heartbeat. Participants will be asked to complete questionnaires about their well-being, which may make some people feel uncomfortable.
Where is the study run from?
This study takes place at Toronto Rehab - University Health Network in Toronto, Ontario, Canada
When is the study starting and how long is it expected to run for?
April 2025 to July 2027. The study starts enrolling in June 2025 and is expected to run for 1 year or until recruitment is complete.
Who is funding the study?
1. The University Health Network Foundation, Canada
2. Princess Margaret Cancer Foundation, Canada
Who is the main contact?
Dr Meiqi Guo, Meiqi.Guo@uhn.ca
Physiatrist and Brain Rehabilitation Program Medical Director, Toronto Rehab
Contact information
Public, Scientific, Principal investigator
550 University Avenue
Toronto, ON
M5G 2A2
Canada
 ORCID ID |
0000-0002-8931-5935 |
|---|---|
| Phone | +1 4165973422 x3424 |
| Meiqi.Guo@uhn.ca |
Public
550 University Avenue
Toronto
Toronto, ON
M5G 2A2
Canada
| ORCID ID |
0000-0003-4318-4076 |
|---|---|
| Phone | +1 4165973422 |
| angie.andreoli@uhn.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot interventional single-blinded randomized controlled trial with embedded qualitative component |
| Secondary study design | Randomised controlled trial |
| Participant information sheet | ISRCTN37366438_PIS_v1.3_15Aug2025.pdf |
| Scientific title | Concurrent teleRehabilitation and Radiation (CoRR) for patients with gliomas |
| Study acronym | CoRR |
| Study objectives | This study has three main objectives: 1) To evaluate the feasibility (recruitment, retention, protocol adherence), safety (adverse events), and preliminary efficacy (cognitive, physical, quality of life outcomes) of an interprofessional, synchronous telerehabilitation program consisting of individualized PT, OT, and/or SLP sessions, compared with usual care among individuals concurrently undergoing radiotherapy for intracranial glioma. 2) To evaluate the feasibility of administering cognitive and physical functioning outcome measures, and to assess quality of life and cancer survival for a future, larger-scale study. 3) To understand patients’ and caregivers’ telerehabilitation experiences, including their perceived barriers and facilitators to participation. |
| Ethics approval(s) |
Approved 07/04/2025, University Health Network Research Ethics Board (LuCliff Place 700 Bay Street, 17th Floor, Suite 1700-01, Toronto, Ontario, M5G 1Z6, Canada; +1 416 581 7849; reb@uhnresearch.ca), ref: 24-5893 |
| Health condition(s) or problem(s) studied | Feasibility and safety of delivering telerehabilitation early and concurrently with radiation therapy for individuals with primary brain tumours |
| Intervention | Current interventions as of 10/11/2025: Intervention arm: Active Rehab Participants in this arm receive outpatient rehabilitation delivered via synchronous, video-based telerehabilitation concurrent to their radiation therapy by a physiotherapist, occupational therapist, and/or speech language pathologist for up to 8 weeks. Active Comparator: Usual Care Participants in this arm receive generic, seated aerobic and strength training exercise instructions, and an online subscription to BrainHQ (exercises for memory, attention and decision-making). Eligible participants will be stratified for glioma grade (grade ≤3, grade=4) and then randomly assigned to either the active care or usual care group using a 1:1 allocation ratio block design. The schedule will be randomly generated by our biostatistician using the PLAN procedure (SAS 9.4, SAS Institute, Inc., USA). Previous interventions: Intervention arm: Active Rehab Participants in this arm receive outpatient rehabilitation delivered via synchronous, video-based telerehabilitation concurrent to their radiation therapy by a physiotherapist, occupational therapist, and/or speech language pathologist for up to 8 weeks. Active Comparator: Usual Care Participants in this arm receive generic, seated aerobic and strength training exercise instructions, and an online subscription to BrainHQ (exercises for memory, attention and decision-making). Eligible participants will be stratified for glioma grade (grade ≤3, grade=4) and then randomly assigned to either the active care or usual care group using a 1:1 allocation ratio block design. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
The percentage of participants who complete the intervention measured using study data from enrollment to the end of the intervention (outpatient telerehabilitation) at 8 weeks |
| Key secondary outcome measure(s) |
1. Recruitment of participants, measured by the percentage of eligible patients who consent to the trial at the point of initial recruitment contact. |
| Completion date | 01/07/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 120 Years |
| Sex | All |
| Target sample size at registration | 54 |
| Key inclusion criteria | 1. 18 years of age of older 2. Planned to undergo an initial course of radiation for a diagnosis of intracranial glioma (any grade) 3. Recent brain surgery (within 12 weeks) 4. Eastern Cooperative Oncology Group (ECOG) performance status greater than (>) 1 at time of enrollment 5. Have a caregiver, friend, or family member available to provide physical support during the initial assessment session and Active Rehab sessions 6. Eligible to be prescribed Brain HQ and home exercises 7. Have an email address, or caregiver, friend or family member has an email address 8. Have cognitive-communicative ability to participate as per clinical judgement 9. Able to provide informed consent, or if not, have a legal decision maker 10. Access to a space with necessary therapy requirements (e.g. must have sturdy chair with armrests; if the room is carpeted, must be low-pile) 11. Able to understand English to the point that they are able to follow instructions and express levels of exertion, pain, distress, etc, as determined by the study team |
| Key exclusion criteria | 1. Undergoing a repeat course of in-field irradiation for a recurrent brain tumour 2. Spinal glioma 3. Currently receiving inpatient or outpatient rehabilitation 4. Living in long-term care 5. Severe vision or hearing loss impacting ability to participate actively in rehabilitation 6. Planned surgery that would preclude or affect participation in the protocol 7. Contraindications to radiation therapy (e.g. pregnancy, or trying to conceive) |
| Date of first enrolment | 13/06/2025 |
| Date of final enrolment | 01/07/2026 |
Locations
Countries of recruitment
- Canada
Study participating centre
Toronto, Ontario
M5G 2A2
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request, Published as a supplement to the results publication |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Meiqi Guo, Co-Principal Investigator, meiqi.guo@uhn.ca The data sets generated and/or analysed during the current study will also be published as a supplement to the results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.3 | 15/08/2025 | 10/11/2025 | No | Yes |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 1.2 | 07/03/2025 | 11/11/2025 | No | No |
Additional files
- ISRCTN37366438_PIS_v1.3_15Aug2025.pdf
- Participant information sheet
- ISRCTN37366438_Protocol_v1.2_07March2025.pdf
- Protocol file
Editorial Notes
11/11/2025: Protocol (not peer reviewed) uploaded.
10/11/2025: Participant information sheet version 1.3 was uploaded, and the interventions were updated with the method of randomisation.
07/11/2025: Study's existence confirmed by the University Health Network, Research Ethics Board, Canada.
