Task-oriented Arm/Hand Skill Rehabilitation and Therapy Dose Dimensions in Subacute Spinal Cord Injury Rehabilitation

NCT ID: NCT05452707

Last Updated: 2023-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-11

Study Completion Date

2023-09-01

Brief Summary

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The study is a multicenter longitudinal observational study. The therapy content and the therapy dosage of arm/skill training for patients with cervical spinal cord injury (SCI) will be observed for the primary objective. The aim is to get insight into the current therapy content and the current therapy dosage in arm/hand skill training, with the overall aim to optimize the arm/hand skill training. For the secondary objective, in addition to the patients with cervical SCI also, patients with paraplegia as a result of SCI are included. The aim is to assess the difference between the patient's perceived dose and the therapist's estimation of the therapy dose. This will give insight into the patient's and therapist's views on therapy dose; this information will contribute to optimizing therapy dose in exercise therapy in SCI. The third aim is a pilot study to explore the usability of evening reports in SCI rehabilitation.

Detailed Description

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Conditions

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Spinal Cord Injuries

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Patients will be observed during their active training sessions.

Patients will be asked questions about:

* fatigue
* physical fatigue
* pain
* the difficulty of the session
* motivation

Observation and questionnaire of active therapy

Intervention Type OTHER

There will be an observation of the usual care; no intervention will be added.

Therapists

Therapists will be asked questions about the observed training sessions of the patients. The questions will be about:

* Estimation of active training time
* Estimation of patient's fatigue
* Estimation of the patient's perceived difficulty of the session
* Estimation of the patient's perceived physical fatigue of the session
* Estimation of the patient's perceived motivation for the session

Observation and questionnaire of active therapy

Intervention Type OTHER

There will be an observation of the usual care; no intervention will be added.

Interventions

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Observation and questionnaire of active therapy

There will be an observation of the usual care; no intervention will be added.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Primary objective

1. Have sustained a traumatic or non-traumatic SCI between C1 and T1.
2. Have an AIS A, B, C or D
3. Are older than 16 years
4. Being able to follow standard arm/hand skill training.
5. Patients in the subacute phase (4-30 weeks post-injury)
6. Receiving usual care
7. Able to understand the purpose of the study (understanding Dutch, English, French and German).
* Secondary objective

Add patients with:

1. Persons with SCI (C1-S4)
2. having an AIS A, B, C, D;
3. Are older than 16 years;
4. Patients in the subacute phase (4-30 weeks post-injury)
5. receiving standard care or more intensive care as defined by the SCI-MT trial - Therapists Physiotherapists, occupational therapists and sports therapists with at least two years of experience in SCI rehabilitation

Exclusion Criteria

1. have any significant medical or physical condition (including pregnancy) or psychiatric illness that could prevent the person from participating in the study
2. are unable/unwilling to provide informed consent.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adelante Zorggroep

UNKNOWN

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Annemie Spooren

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Annemie Spooren, Prof.Dr.

Role: PRINCIPAL_INVESTIGATOR

UHasselt

Locations

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UZ Gent

Ghent, , Belgium

Site Status RECRUITING

UZ Leuven - Campus Pellenberg

Leuven, , Belgium

Site Status RECRUITING

Zorggroep Adelante

Hoensbroek, , Netherlands

Site Status RECRUITING

Countries

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Belgium Netherlands

Central Contacts

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Annemie Spooren, Prof. Dr.

Role: CONTACT

+32 11 26 93 32

Nele Bertels, MSC

Role: CONTACT

+32 11 26 86 92

Other Identifiers

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NB1

Identifier Type: -

Identifier Source: org_study_id

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