Acquired Brain InjuryABI-motionNCT06058351
ABI-aftercare in Motion: Multidisciplinary Aftercare in the Home Environment in Patients With Acquired Brain Injury
A study testing ABI-motion program in people with Acquired Brain Injury, run by Majanka H. Heijenbrok-Kal, PhD at 1 site in Netherlands.
Trial summary
The goal of this implementation study is to improve aftercare for patients with ABI receiving outpatient rehabilitation. The ABI-motion program was developed to improve and active lifestyle and to prevent persistent complaints after ABI and poor HR-QoL.The main questions it aims to answer are: Is the ABI-motion… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- ABI-motion program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2024to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosed with ABI
- Follows an outpatient rehabilitation program for ABI in Rijndam Rehabilitation
Who cannot join
- Having a contra-indication for participation in moderate to vigorous exercise
- Life expectancy < 1 year
- Incapacitated persons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Rijndam Rehabilitation
Rotterdam, 3015LJ
Erik Grauwmeijer, PhD, egrauwmeijer@rijndam.nl
Lianne de Vries, MSc, e.a.devries@erasmusmc.nl
About this study
Official title: ABI-aftercare in Motion: Multidisciplinary Aftercare in the Home Environment in Patients With Acquired Brain Injury; an Implementation Study
The goal of this implementation study is to improve aftercare for patients with ABI receiving outpatient rehabilitation. The ABI-motion program was developed to improve and active lifestyle and to prevent persistent complaints after ABI and poor HR-QoL.The main questions it aims to answer are:
- Is the ABI-motion program feasible?
- What are the health benefits of the ABI-motion program?
Participants will receive brain education, a joint therapy session with a physical or occupational or movement therapist and a buddy from a patient support organization during outpatient rehabilitation, followed by community buddy support after discharge from outpatient rehabilitation, and follow-up by a rehabilitation physician.
Read the detailed description
Rationale: Many people with acquired brain injury (ABI) experience difficulties in reintegration into their social life after discharge from the rehabilitation center. It is also known that people with ABI do not meet the physical activity guidelines; they have lower physical activity levels than healthy people and they have difficulty maintaining their physical fitness level reached during rehabilitation. An inactive lifestyle may lead to persistent complaints, such as fatigue, anxiety or depression, and may result in a poor health-related quality of life (HR-QoL).
Objective: To improve aftercare for patients with ABI receiving outpatient rehabilitation, aimed at promoting an active lifestyle to prevent persistent complaints after ABI and poor HR-QoL.
Study design: Care improvement study using a prospective mono-center cohort with a pre-post implementation study design.
Study population: Patients with ABI receiving outpatient rehabilitation therapy.
Intervention (if applicable): Implementation of an aftercare program that strengthens the cooperation between rehabilitation center and local patient support organisations in the community. The aftercare program integrates standard outpatient rehabilitation and community services, including: 1) brain education regarding long-term consequences of ABI, physical activity guidelines, and patient support organizations in the area; 2) a joint physical/ occupational/ movement therapy session with a buddy from a patient support organisation during outpatient rehabilitation; 3) buddy support (max 8 hrs) in the community towards an active lifestyle after rehabilitation discharge; 4) follow-up by the rehabilitation physician.
Main study parameters/endpoints: The proportion of participants with ABI participating in the community buddy program (target 60%) and feasibility (rating of satisfaction) of the program will be calculated. Secondary, objectively measured physical activity, physical fitness and cognitive functioning and patient reported outcomes (physical activity, fatigue, anxiety, depression, cognitive complaints, coping, community integration, HRQoL, physical fitness, health care use, return to work) using validated questionnaires will be collected before and at 3, 6, and 12 months after outpatient rehabilitation discharge.
- Conditions
- Acquired Brain Injury
- Being tested
- ABI-motion program
- Keywords
- Acquired Brain Injury, Rehabilitation, Aftercare, Implementation
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI-motion programBehavioural
The ABI-motion program strengthens the cooperation between outpatient rehabilitation professionals and community care providers.
| Study group | Role | What they receive |
|---|---|---|
| ABI-motion group | Experimental | Patients following outpatient rehabilitation after implementation of the ABI-motion program Receives: Behavioral: ABI-motion program |
| Control group | No intervention | Patients following outpatient rehabilitation before implementation of the ABI-motion program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in proportion of patients participating in buddy support programs after rehabilitation discharge
Proportion of patients in the ABI-motion group that continues community buddy support after rehabilitation discharge compared with standard care
Measured: 3, 6, 12 months
Mean rating of satisfaction with the ABI-motion program
Satisfaction with the ABI-motion program is rated on a rating scale, ranging from 0 (worst) to 10 (best).
Measured: 12 months
Secondary outcomes (16)
Change in total minutes of physical activity/week at 6 and 12 months compared with controls
Physical activity is measured with an activity monitor (min/week) and electronic diary
Measured: 0, 6, 12 months
Change in Montreal Cognitive Assessment (MoCA) score at 6 and 12 months compared with controls.
The MoCA is a screening tool for detection of mild cognitive impairment. The total score ranges from 0 (worst) to 30 (best).
Measured: 0, 6,12 months
Change in functional exercise capacity at 6 and 12 months compared with controls
The 1-minute Sit-to-Stand Test (1mSTS) measures the number of sit-to-stand transitions during 1 minute.
Measured: 0, 6, 12 months
Change in Walking Speed at 6 and 12 months compared with controls
10 meter Walk Test (10mWT) assesses walking speed (m/s) over a short duration.
Measured: 0, 6, 12 months
Change in handgrip strength at 6 and 12 months compared with controls
Maximum isometric handgrip strength is measured with a hand-held dynamometer over 6 attempts (3 per hand) in kg.
Measured: 0, 6, 12 months
Change in anxiety and depression at 3, 6, and 12 months compared with controls
The Hospital Anxiety and Depression Scale (HADS) subscale scores are used to measure Anxiety and Depression, 7 items each, with subscale scores ranging from 0 (best) to 21 (worst), with scores 0-7 indicating normal sores, 8-10 borderline cases, and 11-21 definite cases of anxiety or depression.
Measured: 0, 3, 6, and 12 months
Change in fatigue at 3, 6, and 12 months compared with controls
The Checklist Individual Strength (CIS) consists of 20 statements on fatigue-related problems respondents might have experienced in the past 2 weeks. The items are rated on a 1-7 point Likert scale, with total scores ranging from 20 (best) to 140 (worst).
Measured: 0, 3, 6, and 12 months
Change in cognitive failures at 3, 6, and 12 months compared with controls
The Cognitive Failures Questionnaire (CFQ) is used to assess the frequency with which people experience cognitive failures in everyday life, such as absent-mindedness, slips and errors of perception, memory, and motor functioning. The total score of the scale is the sum of the ratings of the 25 individual items, yielding a score from 0 (best) to 100 (worst).
Measured: 0, 3, 6, and 12 months
Change in coping style at 3, 6, and 12 months compared with controls
The short version of the Coping Inventory for Stressful Situations (CISS-SF) is used as a measure of coping with stressful situations. It has 21 items which are rated on a 1(no) to 5 (strong) point rating scale. It contains 3 subscales: task-oriented, emotion-oriented, and avoidance-oriented coping. Each subscale score ranges from 7 (low use) to 35 (high use), with higher scores indicating a greater use of that particular coping strategy.
Measured: 0, 3, 6, and 12 months
Change in health-related quality of life at 3, 6, and 12 months compared with controls
The EQ-5D-5L consists of the 5-item EQ-5D index (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) and a visual analogue scale (EQ VAS). The 5 EQ-5D index items are summarized into a weighted overall score, which runs from 0 for the value of death to 1.00 for full health. The EQ VAS ranges from 0 to 100 (worst to best imaginable health state).
Measured: 0, 3, 6, 12 months
Change in physical and mental components of health-related quality of life at 3, 6, and 12 months compared with controls
The Short Form-36 contains 36 items measuring multidimensional quality of life. A physical component summary (PCS) and a mental component summary (MCS) can be calculated, which are T-scores, having a mean of 50 and standard deviation of 10.
Measured: 0, 3, 6, 12 months
Change in physical activity at 3, 6,12 months compared with controls
The International Physical Activity Questionnaire assesses the time spent (min. per week) in several types of physical activity (vigorous activities, moderate activities, walking, and sitting) that people do as part of their daily lives.
Measured: 0, 3, 6, 12 months
Change in fitness at 3, 6,12 months compared with controls
The International Fitness Scale (IFIS) questionnaire gives a measure of fitness based on the answers to 5 basic questions about fitness: physical fitness, cardiorespiratory fitness, muscular fitness, speed-agility, flexibility, and overall fitness, with answers based on a 5-point Likert-scale (1=very poor, to 5=very good).
Measured: 0, 3, 6, 12 months
Change in social participation and health care use at 3, 6, 12 months compared with controls
The Utrecht Scale for Evaluation of Rehabilitation - Participation (USER-P) contains 32 questions with three scales measuring the frequency of participation, perceived participation restrictions, and satisfaction with participation in society. Total scores range from 0 (worst) to 100 (best).
Measured: 0, 3, 6, 12 months
Change in health care use at 3, 6, 12 months compared with controls
The iMTA Medical Consumption Questionnaire is an instrument to measure medical consumption. It includes questions related to the frequency of contacts with health care providers.
Measured: 0, 3, 6, 12 months
Change in medical consumption at 3, 6, 12 months compared with controls
The iMTA Productivity Cost Questionnaire (iPCQ) is used to measure the costs (Dollars and/or Euros) of productivity losses.
Measured: 0, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start1 Mar 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acquired Brain InjuryStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A group of patients will be followed during standard outpatient rehabilitation before and after implementation of the ABI-motion program with 1 year follow-up.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Majanka H. Heijenbrok-Kal, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Brain Foundation
- Responsible party
- Sponsor-investigator, Majanka H. Heijenbrok-Kal, PhD, Erasmus Medical Center
- Investigators
- Gerard M Ribbers, MD, PhD, Study chair, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058351
- Sponsor's protocol ID
- 11172
- Acronym
- ABI-motion
- Status last verified
- Aug 2025
- First submitted
- 8 Sep 2023
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: upon request
Publications
de Vries EA, Grauwmeijer E, Ista E, Blom-De Heer SJ, Cramm JM, Ribbers GM, van den Berg-Emons RJG, Heijenbrok-Kal MH. A multidisciplinary active lifestyle aftercare programme for individuals with acquired brain injury (ABI-MOTION): protocol of a practice-based implementation study. BMJ Open. 2026 Jul 13;16(7):e118358. doi: 10.1136/bmjopen-2026-118358.
PubMed 42442820
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABI-aftercare in Motion: Multidisciplinary Aftercare in the Home Environment in Patients With Acquired Brain Injury; an Implementation Study
- ClinicalTrials.gov ID
- NCT06058351
- Acronym / sponsor ID
- ABI-motion / 11172
- Conditions
- Acquired Brain Injury
- Keywords
- Acquired Brain Injury, Rehabilitation, Aftercare, Implementation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Majanka H. Heijenbrok-Kal, PhDUniversity, hospital or other
- Collaborators
- Netherlands Brain Foundation
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 28 Sep 2023 (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 implementation study is to improve aftercare for patients with ABI receiving outpatient rehabilitation. The ABI-motion program was developed to improve and active lifestyle and to prevent persistent complaints after ABI and poor HR-QoL.The main questions it aims to answer are:
- Is the ABI-motion program feasible?
- What are the health benefits of the ABI-motion program?
Participants will receive brain education, a joint therapy session with a physical or occupational or movement therapist and a buddy from a patient support organization during outpatient rehabilitation, followed by community buddy support after discharge from outpatient rehabilitation, and follow-up by a rehabilitation physician.
Detailed description
Rationale: Many people with acquired brain injury (ABI) experience difficulties in reintegration into their social life after discharge from the rehabilitation center. It is also known that people with ABI do not meet the physical activity guidelines; they have lower physical activity levels than healthy people and they have difficulty maintaining their physical fitness level reached during rehabilitation. An inactive lifestyle may lead to persistent complaints, such as fatigue, anxiety or depression, and may result in a poor health-related quality of life (HR-QoL).
Objective: To improve aftercare for patients with ABI receiving outpatient rehabilitation, aimed at promoting an active lifestyle to prevent persistent complaints after ABI and poor HR-QoL.
Study design: Care improvement study using a prospective mono-center cohort with a pre-post implementation study design.
Study population: Patients with ABI receiving outpatient rehabilitation therapy.
Intervention (if applicable): Implementation of an aftercare program that strengthens the cooperation between rehabilitation center and local patient support organisations in the community. The aftercare program integrates standard outpatient rehabilitation and community services, including: 1) brain education regarding long-term consequences of ABI, physical activity guidelines, and patient support organizations in the area; 2) a joint physical/ occupational/ movement therapy session with a buddy from a patient support organisation during outpatient rehabilitation; 3) buddy support (max 8 hrs) in the community towards an active lifestyle after rehabilitation discharge; 4) follow-up by the rehabilitation physician.
Main study parameters/endpoints: The proportion of participants with ABI participating in the community buddy program (target 60%) and feasibility (rating of satisfaction) of the program will be calculated. Secondary, objectively measured physical activity, physical fitness and cognitive functioning and patient reported outcomes (physical activity, fatigue, anxiety, depression, cognitive complaints, coping, community integration, HRQoL, physical fitness, health care use, return to work) using validated questionnaires will be collected before and at 3, 6, and 12 months after outpatient rehabilitation discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A group of patients will be followed during standard outpatient rehabilitation before and after implementation of the ABI-motion program with 1 year follow-up.
| Arm | Type | Receives |
|---|---|---|
| ABI-motion group | Experimental | Behavioral: ABI-motion programPatients following outpatient rehabilitation after implementation of the ABI-motion program |
| Control group | No intervention | –Patients following outpatient rehabilitation before implementation of the ABI-motion program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with ABI
- Follows an outpatient rehabilitation program for ABI in Rijndam Rehabilitation
Key exclusion criteria (3 listed)
- Having a contra-indication for participation in moderate to vigorous exercise
- Life expectancy < 1 year
- Incapacitated persons
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 |
|---|---|---|
| ABI-motion programThe ABI-motion program strengthens the cooperation between outpatient rehabilitation professionals and community care providers. | Behavioural | ABI-motion group |
Primary outcome
Difference in proportion of patients participating in buddy support programs after rehabilitation discharge
Time frame: 3, 6, 12 months
Proportion of patients in the ABI-motion group that continues community buddy support after rehabilitation discharge compared with standard care
Mean rating of satisfaction with the ABI-motion program
Time frame: 12 months
Satisfaction with the ABI-motion program is rated on a rating scale, ranging from 0 (worst) to 10 (best).
16 secondary outcomes
Change in total minutes of physical activity/week at 6 and 12 months compared with controls
Time frame: 0, 6, 12 months
Change in Montreal Cognitive Assessment (MoCA) score at 6 and 12 months compared with controls.
Time frame: 0, 6,12 months
Change in functional exercise capacity at 6 and 12 months compared with controls
Time frame: 0, 6, 12 months
Change in Walking Speed at 6 and 12 months compared with controls
Time frame: 0, 6, 12 months
Change in handgrip strength at 6 and 12 months compared with controls
Time frame: 0, 6, 12 months
Change in anxiety and depression at 3, 6, and 12 months compared with controls
Time frame: 0, 3, 6, and 12 months
Change in fatigue at 3, 6, and 12 months compared with controls
Time frame: 0, 3, 6, and 12 months
Change in cognitive failures at 3, 6, and 12 months compared with controls
Time frame: 0, 3, 6, and 12 months
Change in coping style at 3, 6, and 12 months compared with controls
Time frame: 0, 3, 6, and 12 months
Change in health-related quality of life at 3, 6, and 12 months compared with controls
Time frame: 0, 3, 6, 12 months
Change in physical and mental components of health-related quality of life at 3, 6, and 12 months compared with controls
Time frame: 0, 3, 6, 12 months
Change in physical activity at 3, 6,12 months compared with controls
Time frame: 0, 3, 6, 12 months
Change in fitness at 3, 6,12 months compared with controls
Time frame: 0, 3, 6, 12 months
Change in social participation and health care use at 3, 6, 12 months compared with controls
Time frame: 0, 3, 6, 12 months
Change in health care use at 3, 6, 12 months compared with controls
Time frame: 0, 3, 6, 12 months
Change in medical consumption at 3, 6, 12 months compared with controls
Time frame: 0, 3, 6, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Derived from this study: PubMed 42442820de Vries EA, Grauwmeijer E, Ista E, Blom-De Heer SJ, Cramm JM, Ribbers GM, van den Berg-Emons RJG, Heijenbrok-Kal MH. A multidisciplinary active lifestyle aftercare programme for individuals with acquired brain injury (ABI-MOTION): protocol of a practice-based implementation study. BMJ Open. 2026 Jul 13;16(7):e118358. doi: 10.1136/bmjopen-2026-118358.
- Individual participant dataSharing planned: Yes. upon request
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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.
Gerard M Ribbers, MD, PhD study chair
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ABI-motion program in people with Acquired Brain Injury, run by Majanka H. Heijenbrok-Kal, PhD at 1 site in Netherlands.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 29 Aug 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 Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Majanka H Heijenbrok-Kal, PhD (+31628129140, m.heijenbrok@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in proportion of patients participating in buddy support programs after rehabilitation discharge (time frame: 3, 6, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06058351, which also lists 1 linked publication.
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 29 Aug 2025.