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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05452707
Enrollment
47
Registered
2022-07-11
Start date
2022-07-11
Completion date
2023-09-01
Last updated
2023-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

Keywords

Spinal cord rehabilitation, Therapy content in arm/hand skill training, Therapy dose in spinal cord rehabilitation

Brief summary

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.

Interventions

OTHERObservation and questionnaire of active therapy

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

Sponsors

Adelante Zorggroep
CollaboratorUNKNOWN
Universitaire Ziekenhuizen KU Leuven
CollaboratorOTHER
University Ghent
CollaboratorOTHER
Hasselt University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Task-oriented and therapy dose dimensions and the change in time of these components in arm/hand skill training in usual care in cervical SCI during subacute rehabilitationPatients will be observed for three weeks between 4 and 20 weeks post-injury. There will be three random days of observations. Data will be collected from every therapy session with at least 50% arm/hand skill training* An observer reports the therapy content (endurance training, strength training and skill training) on a data report * Active training time is measured with accelerometers on both wrists * An observer with a hand counter measures movement repetitions * The prescribed, planned and given therapy hours are reported on a data form

Secondary

MeasureTime frameDescription
Perceived dose in spinal cord injury in the subacute rehabilitationPatients will be observed for three weeks between 4 and 20 weeks post-injury. There will be three random days of observations. Data will be collected before and after every active therapy session.Patients and therapists answers questions before and after the sessions Patients get questions on: * Fatigue * Pain * Difficulty * Physical fatigue * Motivation Therapists get questions on: * 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 of the session

Other

MeasureTime frameDescription
Pilot study: usability of evening reports in rehabilitation of SCI.Patients will be observed for three weeks between 4 and 20 weeks post-injury. There will be three random days of observations. Data will be collected in the evening after the active therapy session.Patients get questions on a evening report the themes are: * Pain * Fatigue * Motivation * Satisfaction * Acceptance * General mood Patients get questions on a evening report the themes are: * Pain * Fatigue * Motivation * Satisfaction * Acceptance * General mood

Countries

Belgium, Netherlands

Contacts

Primary ContactAnnemie Spooren, Prof. Dr.
annemie.spooren@uhasselt.be+32 11 26 93 32
Backup ContactNele Bertels, MSC
nele.bertels@uhasselt.be+32 11 26 86 92

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026