Acquired Brain Injury (Including Stroke)NCT06952595
Carer Involvement in Exercises for People With Acquired Brain Injury.
A study testing five exercises prescribed and taught to carers and participants in people with Acquired Brain Injury (Including Stroke), run by Norfolk and Norwich University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Increasing the amount of exercises completed has been shown to help recovery for people after a brain injury. This study will explore if providing extra training of exercises prescribed to a patient and carer team, will allow more practice of these exercises, better abilities to move and balance, and to assess if… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury (Including Stroke)
- What is being tested?
- five exercises prescribed and taught to carers and participants
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jun 2024to 13 Sep 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
- Adults with acquired brain injury on NNUH Neurosciences Unit with a carer physically able to complete exercises with the patient.
- Patient to be able to follow simple commands (1 stage) for exercise intervention.
- Patient able to consent along with their relative together to participation in the study.
Who cannot join
- Discharge plan for ESD from initial assessment with no care package required due to too short timeframe of being an acute in-patient.
- Patient's with severe cognitive - communication deficits meaning they cannot follow 1 stage command for exercises or consent to the study.
- Severe pain, joint abnormality or spasticity limiting participation in exercise programme.
- Carer/relative not able to physically help the patient with the required exercises or carer/relative not able to consent to the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich
About this study
Official title: Carer Involvement in Exercise Programmes for Acute Neurosciences Patients With Acquired Brain Injury
Increasing the amount of exercises completed has been shown to help recovery for people after a brain injury. This study will explore if providing extra training of exercises prescribed to a patient and carer team, will allow more practice of these exercises, better abilities to move and balance, and to assess if carer confidence changes with doing this. It is a repeated case design in the in-patient acute Neurosciences setting at the Norfolk and Norwich University Hospital NHS Trust (NNUH).
- Conditions
- Acquired Brain Injury (Including Stroke)
- Being tested
- five exercises prescribed and taught to carers and participants
- Keywords
- Stoke, Acquired brain injury, rehabilitation, exercise therapy
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
five exercises prescribed and taught to carers and participantsBehavioural
Up to five exercises prescribed and taught to carers and participants in an acute hospital setting fort hem to continue to practice as able.
| Study group | Role | What they receive |
|---|---|---|
| Exercises for people with acquired brain injury | Experimental | Not described Receives: Behavioral: five exercises prescribed and taught to carers and participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Log of exercise repetitions
Log of exercise repetitions completed by patient and relative/carer team (on exercise record log), VAS score (Visual analogue score) rating 0- no confidence to 10- very confident for carer confidence pre and post intervention.
Measured: Pre and post intervention: 4 weeks or at point of discharge from acute Trust.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start3 Jun 2024
- Primary completion23 Aug 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain Injury (Including Stroke)Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of East Anglia, 3 Million Steps charity
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952595
- Sponsor's protocol ID
- 334551 (196-10-23)
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2025
- Last updated
- 1 May 2025
- 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 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carer Involvement in Exercise Programmes for Acute Neurosciences Patients With Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT06952595
- Acronym / sponsor ID
- 334551 (196-10-23)
- Conditions
- Acquired Brain Injury (Including Stroke)
- Keywords
- Stoke, Acquired brain injury, rehabilitation, exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of East Anglia, 3 Million Steps charity
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 23 Aug 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 1 May 2025 (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.
Increasing the amount of exercises completed has been shown to help recovery for people after a brain injury. This study will explore if providing extra training of exercises prescribed to a patient and carer team, will allow more practice of these exercises, better abilities to move and balance, and to assess if carer confidence changes with doing this. It is a repeated case design in the in-patient acute Neurosciences setting at the Norfolk and Norwich University Hospital NHS Trust (NNUH).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercises for people with acquired brain injury | Experimental | Behavioral: five exercises prescribed and taught to carers and participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults with acquired brain injury on NNUH Neurosciences Unit with a carer physically able to complete exercises with the patient.
- Patient to be able to follow simple commands (1 stage) for exercise intervention.
- Patient able to consent along with their relative together to participation in the study.
Key exclusion criteria (4 listed)
- Discharge plan for ESD from initial assessment with no care package required due to too short timeframe of being an acute in-patient.
- Patient's with severe cognitive - communication deficits meaning they cannot follow 1 stage command for exercises or consent to the study.
- Severe pain, joint abnormality or spasticity limiting participation in exercise programme.
- Carer/relative not able to physically help the patient with the required exercises or carer/relative not able to consent to the 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 |
|---|---|---|
| five exercises prescribed and taught to carers and participantsUp to five exercises prescribed and taught to carers and participants in an acute hospital setting fort hem to continue to practice as able. | Behavioural | Exercises for people with acquired brain injury |
Primary outcome
Log of exercise repetitions
Time frame: Pre and post intervention: 4 weeks or at point of discharge from acute Trust.
Log of exercise repetitions completed by patient and relative/carer team (on exercise record log), VAS score (Visual analogue score) rating 0- no confidence to 10- very confident for carer confidence pre and post intervention.
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 1 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing five exercises prescribed and taught to carers and participants in people with Acquired Brain Injury (Including Stroke), run by Norfolk and Norwich University Hospitals NHS Foundation Trust 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 3 inclusion and 4 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 1 May 2025. 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?
Log of exercise repetitions (time frame: Pre and post intervention: 4 weeks or at point of discharge from acute Trust.). 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 1 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.