- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06952595
Carer Involvement in Exercises for People With Acquired Brain Injury.
April 28, 2025 updated by: Norfolk and Norwich University Hospitals NHS Foundation Trust
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Norwich, United Kingdom
- Norfolk and Norwich University Hospitals NHS Foundation Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion
- 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.
Exclusion:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercises for people with acquired brain injury
|
Up to five exercises prescribed and taught to carers and participants in an acute hospital setting fort hem to continue to practice as able.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Pre and post intervention: 4 weeks or at point of discharge from acute Trust.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 3, 2024
Primary Completion (Actual)
August 23, 2024
Study Completion (Actual)
September 13, 2024
Study Registration Dates
First Submitted
April 2, 2025
First Submitted That Met QC Criteria
April 28, 2025
First Posted (Actual)
May 1, 2025
Study Record Updates
Last Update Posted (Actual)
May 1, 2025
Last Update Submitted That Met QC Criteria
April 28, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 334551 (196-10-23)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.