NCT06058351

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Mar 2024Mar 2027

First Submitted

Initial submission to the registry

September 8, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

2.8 years

First QC Date

September 8, 2023

Last Update Submit

August 28, 2025

Conditions

Keywords

Acquired Brain InjuryRehabilitationAftercareImplementation

Outcome Measures

Primary Outcomes (2)

  • 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

    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).

    12 months

Secondary Outcomes (16)

  • Change in total minutes of physical activity/week at 6 and 12 months compared with controls

    0, 6, 12 months

  • Change in Montreal Cognitive Assessment (MoCA) score at 6 and 12 months compared with controls.

    0, 6,12 months

  • Change in functional exercise capacity at 6 and 12 months compared with controls

    0, 6, 12 months

  • Change in Walking Speed at 6 and 12 months compared with controls

    0, 6, 12 months

  • Change in handgrip strength at 6 and 12 months compared with controls

    0, 6, 12 months

  • +11 more secondary outcomes

Study Arms (2)

ABI-motion group

EXPERIMENTAL

Patients following outpatient rehabilitation after implementation of the ABI-motion program

Behavioral: ABI-motion program

Control group

NO INTERVENTION

Patients following outpatient rehabilitation before implementation of the ABI-motion program

Interventions

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

ABI-motion group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rijndam Rehabilitation

Rotterdam, 3015LJ, Netherlands

RECRUITING

MeSH Terms

Conditions

Brain Injuries

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Gerard M Ribbers, MD, PhD

    Erasmus Medical Center

    STUDY CHAIR

Central Study Contacts

Majanka H Heijenbrok-Kal, PhD

CONTACT

Erik Grauwmeijer, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical epidemiologist

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 28, 2023

Study Start

March 1, 2024

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

August 29, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations