Spinal Cord InjuriesNCT06583538
An Online Rehabilitation Programme for People with SCI
A study testing Giraffe Healthcare in people with Spinal Cord Injuries and Physical Inactivity, run by Glasgow Caledonian University at 1 site in United Kingdom.
Trial summary
The goal of this feasibility study is to explore the feasibility and effectiveness of a 12-week online rehabilitation programme in people with Spinal Cord Injury during the transition from hospital to home. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Physical Inactivity, Spinal Cord Injury, Acute
- What is being tested?
- Giraffe Healthcare
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Nov 2023to 8 Oct 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatient at the Queen Elizabeth National Spinal Injuries Unit
- Incomplete or complete spinal cord injury of less than one year in duration
- Medically stable to engage in physical rehabilitation and physical activity
- Able to engage in manual wheelchair propulsion and / or weight baring activities
- Discharge date anticipated within the next 4 weeks
- Access and capability to use the internet
Who cannot join
- Under 18 years old
- Chronic spinal cord injury patients more than one year since injury
- Discharge planned to another hospital or care facility
- Co-morbidities which would preclude taking part in a physical activity programme: medically diagnosed ischemic heart disease; unstable angina, dysrhythmia or unstable autonomic dysreflexia; recent osteoporotic fracture, tracheostomy, current pressure injury, current substance dependence, psychosis, severe chronic upper extremity pain, surgery pending within 6 months, recurrent infection or illness requiring hospitalization (Bombardier et al., 2021).
- Those who do not wish to take part in a physical activity research study
- Unable to understand written and spoken English language
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Elizabeth National Spinal Injuries Unit
Glasgow, Scotland, G51 4TF
About this study
Official title: An Online Rehabilitation Programme to Support Physical Activity Adherence and Functional Capacity in People with Spinal Cord Injury Following Discharge Into the Community: a Feasibility Study
The goal of this feasibility study is to explore the feasibility and effectiveness of a 12-week online rehabilitation programme in people with Spinal Cord Injury during the transition from hospital to home.
The main question[s] it aims to answer are:
Read more
- What is the feasibility of an online rehabilitation programme to support physical activity adherence in people with spinal cord injury following discharge into the community?
- How effective is an online rehabilitation programme to enhance functional capacity, physical activity and quality of life in people with spinal cord injury following discharge into the community?
Participants will be given a personalised online rehabilitation programme to complete two times a week. It will consist of a warm up two exercise components (cardiorespiratory fitness and muscle strength) and a cool down.
Read the detailed description
Bridging the gap between the inpatient setting to the home environment is essential to promote Physical Activity (PA) adherence, improve functional independence and enhance quality of life by implementing lifelong exercise habits. To our knowledge, no study has investigated the feasibility of an online rehabilitation programme among sub-acute Spinal Cord Injury (SCI) patients during this important discharge period from hospital to home. Therefore, this study will explore the feasibility and effectiveness of a 12-week online rehabilitation programme in people with SCI during the transition from hospital to home.
All subacute inpatients who are undergoing their first episode of inpatient rehabilitation post SCI at the Queen Elizabeth National Spinal Injuries Unit (QENSIU) who fulfil the inclusion criteria will be invited to take part in the current study. A rehabilitation programme will be prescribed individually for each participant. Each programme will align with the current PA guidelines for adults with SCI and will be tailored to the participants ability. Participants will be advised to complete the programme twice per week. It will consist of 20 mins cardiorespiratory followed by a strengthening session. Therefore, the participants will engage in the programme for roughly 40 minutes twice per week. The participants will be instructed to log all completed sessions in an online diary so adherence and duration of PA can be monitored.
Assessment will consist of 4 phases, two in person assessments at baseline and 6 weeks post discharge and two remote (online) assessments at 2 and 12 weeks post discharge. Each assessment will consist of quantitative outcome measures. Additionally, a subset of the study sample will take part in a qualitative structured video interview at the end of their intervention period.
- Being tested
- Giraffe Healthcare
- Medical subject headings
- Spinal Cord Injuries, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Giraffe HealthcareOther
An online personalised rehabilitation platform consisting of exercise videos with written and audio instruction, an exercise diary, advice and in-built messaging system between therapist and participant.
The exercise prescription consists of strengthening, aerobic and stretching. 40mins per session, twice per week, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Online Exercise | Experimental | Online personalised rehabilitation consisting of strengthening, aerobic and stretching. 40mins per session, twice per week, for 12 weeks Receives: Other: Giraffe Healthcare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence
Adherence will be monitored remotely by the number of online diary entries per participant.á Adherence will then be calculated based on percentage of completed sessions per week over the 12 weeks.Following the guidelines, the optimum number of completed sessions per participant is 2 x 20 mins cardiorespiratory and 2 strengthening per week. >75% = excellent , 50-75% = good, <50% = satisfactory, <25% = low.
Measured: 12 weeks
Acceptability
Acceptability will be captured by the structured online video interview. Thematic analysis will be used to assess the qualitative data.
Measured: Week 6 to week 12
Participant recruitment and retention
Measured by assessing participant eligibility (number of those approached and those who meet the inclusion criteria), recruitment rate per month and retention of recruited participants.
Measured: 12 weeks
Secondary outcomes (7)
Self-report Physical Activity Scale for individuals with Physical Disabilities (PASIPD)
Captures information about leisure, household and work-related activity over the preceding 7 days.The PASIPD calculates scores by multiplying the time spent on each activity by a metabolic equivalent value (MET) and then adding the results together with a maximum score of 199.5. Individuals respond to 2 ordinally ranked responses. Frequency responses range from 1 (never) to 4 (often) while duration responses range from 1 (less than 1) hour to 4 (greater than 4 hours).
Measured: Baseline, Week 2, Week 6 and week 12
6-minute wheelchair test (6minWCT) OR 6-minute walk test (6MinWT)
Assesses functional capacity and endurance
Measured: Baseline and week 6
Muscle Strength in kg
Via manual muscle dynamometer
Measured: Baseline and week 6
Borg Rate of Perceived Exertion (RPE) Scale
Collected after 6 minute test. 6-20 point self-reported scale based on rate of perceived exertion with 6 being minimum and 20 being maximum.
Measured: Baseline and week 6
Walking Index for Spinal Cord Injury (WISCI II)
Assesses improvement in walking ability. Measures type and level of assistance required for walking 10m. Minimum = 0, Maximum = 20.
Measured: Baseline and week 6
Spinal Cord Independence Measure Self Report (SCIM III SR)
Performance in activities of daily living and mobility questionnaire.The SCIM-SR assesses the degree of independence an individual with SCI has in 3 categories; self-care, respiration and sphincter management and mobility. A higher score indicates greater functional independence. Maximum = 100.
Measured: Baseline, Week 2, Week 6 and week 12
World Health Organisation Quality of Life-Bref Scale (WHOQoL-Bref)
Quality of life questionnaire measures 4 domains: physical, psychological, social and environmental health. Higher score indicates greater quality of life. Maximum = 400.
Measured: Baseline, Week 2, Week 6 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start22 Nov 2023
- Primary completion8 Oct 2024
- Study completion8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elaine Coulter, PhD, Study chair, Glasgow Caledonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06583538
- Sponsor's protocol ID
- 331702
- Status last verified
- Nov 2024
- First submitted
- 15 Dec 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Online Rehabilitation Programme to Support Physical Activity Adherence and Functional Capacity in People with Spinal Cord Injury Following Discharge Into the Community: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06583538
- Acronym / sponsor ID
- 331702
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 4 Sep 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 feasibility study is to explore the feasibility and effectiveness of a 12-week online rehabilitation programme in people with Spinal Cord Injury during the transition from hospital to home.
The main question[s] it aims to answer are:
- What is the feasibility of an online rehabilitation programme to support physical activity adherence in people with spinal cord injury following discharge into the community?
- How effective is an online rehabilitation programme to enhance functional capacity, physical activity and quality of life in people with spinal cord injury following discharge into the community?
Participants will be given a personalised online rehabilitation programme to complete two times a week. It will consist of a warm up two exercise components (cardiorespiratory fitness and muscle strength) and a cool down.
Detailed description
Bridging the gap between the inpatient setting to the home environment is essential to promote Physical Activity (PA) adherence, improve functional independence and enhance quality of life by implementing lifelong exercise habits. To our knowledge, no study has investigated the feasibility of an online rehabilitation programme among sub-acute Spinal Cord Injury (SCI) patients during this important discharge period from hospital to home. Therefore, this study will explore the feasibility and effectiveness of a 12-week online rehabilitation programme in people with SCI during the transition from hospital to home.
All subacute inpatients who are undergoing their first episode of inpatient rehabilitation post SCI at the Queen Elizabeth National Spinal Injuries Unit (QENSIU) who fulfil the inclusion criteria will be invited to take part in the current study. A rehabilitation programme will be prescribed individually for each participant. Each programme will align with the current PA guidelines for adults with SCI and will be tailored to the participants ability. Participants will be advised to complete the programme twice per week. It will consist of 20 mins cardiorespiratory followed by a strengthening session. Therefore, the participants will engage in the programme for roughly 40 minutes twice per week. The participants will be instructed to log all completed sessions in an online diary so adherence and duration of PA can be monitored.
Assessment will consist of 4 phases, two in person assessments at baseline and 6 weeks post discharge and two remote (online) assessments at 2 and 12 weeks post discharge. Each assessment will consist of quantitative outcome measures. Additionally, a subset of the study sample will take part in a qualitative structured video interview at the end of their intervention period.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Online Exercise | Experimental | Other: Giraffe HealthcareOnline personalised rehabilitation consisting of strengthening, aerobic and stretching. 40mins per session, twice per week, for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Inpatient at the Queen Elizabeth National Spinal Injuries Unit
- Incomplete or complete spinal cord injury of less than one year in duration
- Medically stable to engage in physical rehabilitation and physical activity
- Able to engage in manual wheelchair propulsion and / or weight baring activities
- Discharge date anticipated within the next 4 weeks
Key exclusion criteria (6 listed)
- Under 18 years old
- Chronic spinal cord injury patients more than one year since injury
- Discharge planned to another hospital or care facility
- Co-morbidities which would preclude taking part in a physical activity programme: medically diagnosed ischemic heart disease; unstable angina, dysrhythmia or unstable autonomic dysreflexia; recent osteoporotic fracture, tracheostomy, current pressure injury, current substance dependence, psychosis, severe chronic upper extremity pain, surgery pending within 6 months, recurrent infection or illness requiring hospitalization (Bombardier et al., 2021).
- Those who do not wish to take part in a physical activity research study
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 |
|---|---|---|
| Giraffe HealthcareAn online personalised rehabilitation platform consisting of exercise videos with written and audio instruction, an exercise diary, advice and in-built messaging system between therapist and participant. The exercise prescription consists of strengthening, aerobic and stretching. 40mins per session, twice per week, for 12 weeks | Other | Online Exercise |
Primary outcome
Adherence
Time frame: 12 weeks
Adherence will be monitored remotely by the number of online diary entries per participant.á Adherence will then be calculated based on percentage of completed sessions per week over the 12 weeks.Following the guidelines, the optimum number of completed sessions per participant is 2 x 20 mins cardiorespiratory and 2 strengthening per week. >75% = excellent , 50-75% = good, <50% = satisfactory, <25% = low.
Acceptability
Time frame: Week 6 to week 12
Acceptability will be captured by the structured online video interview. Thematic analysis will be used to assess the qualitative data.
Participant recruitment and retention
Time frame: 12 weeks
Measured by assessing participant eligibility (number of those approached and those who meet the inclusion criteria), recruitment rate per month and retention of recruited participants.
7 secondary outcomes
Self-report Physical Activity Scale for individuals with Physical Disabilities (PASIPD)
Time frame: Baseline, Week 2, Week 6 and week 12
6-minute wheelchair test (6minWCT) OR 6-minute walk test (6MinWT)
Time frame: Baseline and week 6
Muscle Strength in kg
Time frame: Baseline and week 6
Borg Rate of Perceived Exertion (RPE) Scale
Time frame: Baseline and week 6
Walking Index for Spinal Cord Injury (WISCI II)
Time frame: Baseline and week 6
Spinal Cord Independence Measure Self Report (SCIM III SR)
Time frame: Baseline, Week 2, Week 6 and week 12
World Health Organisation Quality of Life-Bref Scale (WHOQoL-Bref)
Time frame: Baseline, Week 2, Week 6 and week 12
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 22 Nov 2024.
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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.
Elaine Coulter, PhD study chair
Glasgow Caledonian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Giraffe Healthcare in people with Spinal Cord Injuries and Physical Inactivity, run by Glasgow Caledonian University at 1 site in United Kingdom.
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 6 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 22 Nov 2024. 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 United Kingdom. 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 (time frame: 12 weeks). The study lists 3 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 22 Nov 2024.