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Recruiting NCT06058351

ABI-aftercare in Motion: Multidisciplinary Aftercare in the Home Environment in Patients With Acquired Brain Injury

No phase Interventional Acquired Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ABI-motion program.
Who it may be relevant to
Registry conditions: Acquired Brain Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

ABI-aftercare in Motion: Multidisciplinary Aftercare in the Home Environment in Patients With Acquired Brain Injury; an Implementation Study

Overview

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.

Interventions

  • Behavioral ABI-motion program
    The ABI-motion program strengthens the cooperation between outpatient rehabilitation professionals and community care providers.

Primary outcome measures

  • Difference in proportion of patients participating in buddy support programs after rehabilitation discharge [Time frame: 3, 6, 12 months]
  • Mean rating of satisfaction with the ABI-motion program [Time frame: 12 months]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Inclusion criteria

  • Diagnosed with ABI
  • Follows an outpatient rehabilitation program for ABI in Rijndam Rehabilitation

Exclusion criteria

  • Having a contra-indication for participation in moderate to vigorous exercise
  • Life expectancy < 1 year
  • Incapacitated persons

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Supportive care

Study locations

Netherlands · 1 center
  • Rijndam Rehabilitation — Rotterdam

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. PMID 42442820

Identifiers

NCT: NCT06058351 · 11172

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗