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iN home Telerehabilitation to ENhance phySIcal activiTY after Stroke (iNTENSITY - Stroke)

The efficacy of home-delivered telerehabilitation compared with centre-based community rehabilitation on time spent physically active in people with stroke: a pilot randomized controlled trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000418976
Acronym
iNTENSITY - Stroke
Enrollment
60
Registered
2020-03-30
Start date
2020-11-01
Completion date
2021-11-01
Last updated
2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Community rehabilitation after stroke may be limited due to factors as difficulties getting to appointments and limited access. Telerehabilitation, delivery of rehabilitation through communication technologies has emerged as a promising platform, and may overcome many of these difficulties. The primary aim of the pilot Randomized Controlled Trial (RCT) is to determine the effect of home-delivered telerehabilitation on physical activity compared with centre-based community rehabilitation in people with stroke with matched scheduled therapy time across both interventions. We hypothesize that people with stroke who receive home-delivered telerehabilitation will demonstrate 1) Increased daily physical activity and 2) better clinical, patient related and economic outcomes when compared with those receiving centre-based community rehabilitation.

Interventions

2 cohorts: Participants will be randomised to a home-delivered telerehabilitation or centre-based community rehabilitation cohort. Participants will receive 6 weeks of rehabilitation delivered over a 6-8 weeks period. Both groups will receive the same amount of total scheduled therapy time related to physical activity: Totaling 2 hours of Physiotherapy and/or Occupational Therapy time and 2 hours of Allied Health Assistant therapy time per week. Both intervention arms will provide individuall

2 cohorts: Participants will be randomised to a home-delivered telerehabilitation or centre-based community rehabilitation cohort. Participants will receive 6 weeks of rehabilitation delivered over a 6-8 weeks period. Both groups will receive the same amount of total scheduled therapy time related to physical activity: Totaling 2 hours of Physiotherapy and/or Occupational Therapy time and 2 hours of Allied Health Assistant therapy time per week. Both intervention arms will provide individually tailored task-specific exercises targeting physical activity. In addition, both intervention arms will coach, educate and mentor participants in self-managing their physical activities in daily life. Further, both interventions will use patient specific goal setting and follow therapy recommendations as outlined by the Australian Stroke National Guidelines. The need for physiotherapy or occupational therapy, including duration of sessions will be determined based on how participants can best achieve their specific goals. Intervention administration: Participants randomised to home-delivered telerehabilitation will receive rehabilitation delivered at their residential address through a technology device e.g. tablet, computer. Participants will receive 2 hours rehabilitation from a physiotherapist and/or occupational therapist and 2 hours of rehabilitation delivered from an Allied Health Assistant per week. Participants randomised to centre-based community rehabilitation will travel to their nearest centre for rehabilitation. Patient will receive 2 hours rehabilitation from a physiotherapist and/or occupational therapist and 2 hours of rehabilitation delivered from an Allied Health Assistant per week. Mode of therapy administration: Participants randomised to home-delivered telerehabilitation will receive rehabilitation delivered through a technology device. Participants randomised to centre-based rehabilitation will be delivered in a one-on-one or/and in a group session (max 8 people). All aspects of the delivered therapy will be monitored and recorded: Service delivery fidelity 1) Start and end time of intervention session 2) Health professional involved (PT/OT or AHA) 3) Frequency of sessions/ total sessions 4) Attendance/ cancelled/ did not attend/ rescheduled (includes reason technology failures) 5) Caregiver attendance Y/N – Caregiver presence required Y/N Therapy content fidelity 1) Content of sessions in ‘active minutes’ spent on physical activity 2) Content of sessions in minutes on rest, self-management, education, goal setting, documentation, and other non-patient contact time. 3) Time to set up session

Sponsors

Sunshine Coast Hospital and Health Service
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

>18 years of age First or recurrent stroke (ischemic and hemorrhagic) A modified Rankin Scale (mRS) of 1, 2, 3 or 4 on discharge from hospital (acute or subacute inpatient) Presence of motor impairments Able to engage in rehabilitation through information technology Own technology device (or loan tablet) and data plan to support telerehabilitation Able to sign consent or has a substitute decision maker who can sign consent (pending governance approvals for substitute decision maker consent from QCAT)

Exclusion criteria

Premorbid mRS>3 Concurrent progressive neurologic disorder including severe dementia End-stage medical/ palliative conditions with life expectancy <6 months Severe aphasia (unable to follow one stage commands)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026