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

NCT05452707 | Unknown

• 1 other identifier: NB1
• Study Type: observational
• Target: 47
• Locations: 2 countries
• Sites: 3

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.

Conditions

Spinal Cord Injuries

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 rehabilitation

  * 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

  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 from every therapy session with at least 50% arm/hand skill training

Secondary Outcomes (1)

• Perceived dose in spinal cord injury in the subacute rehabilitation

  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 before and after every active therapy session.

Other Outcomes (1)

• 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.

Study Arms (2)

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

Other: Observation and questionnaire of active therapy

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

Other: Observation and questionnaire of active therapy

Interventions

Observation and questionnaire of active therapy OTHER

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

Patients; Therapists

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients during the subacute phase (0-12 months post-injury) of a spinal cord injury. Therapists who give active training to patients in the subacute phase (0-12 months post-injury) of a spinal cord injury.

You may qualify if:

• Primary objective
• Have sustained a traumatic or non-traumatic SCI between C1 and T1.
• Have an AIS A, B, C or D
• Are older than 16 years
• Being able to follow standard arm/hand skill training.
• Patients in the subacute phase (4-30 weeks post-injury)
• Receiving usual care
• Able to understand the purpose of the study (understanding Dutch, English, French and German).
• Secondary objective
• Add patients with:
• Persons with SCI (C1-S4)
• having an AIS A, B, C, D;
• Are older than 16 years;
• Patients in the subacute phase (4-30 weeks post-injury)
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hasselt University: lead
• Adelante Zorggroep: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator
• University Ghent: collaborator

Study Sites (3)

UZ Gent

Ghent, Belgium

RECRUITING

UZ Leuven - Campus Pellenberg

Leuven, Belgium

RECRUITING

Zorggroep Adelante

Hoensbroek, Netherlands

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Observation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Annemie Spooren, Prof.Dr.

  UHasselt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annemie Spooren, Prof. Dr.

CONTACT

+32 11 26 93 32; annemie.spooren@uhasselt.be

Nele Bertels, MSC

CONTACT

+32 11 26 86 92; nele.bertels@uhasselt.be

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: July 11, 2022
• Study Start: July 11, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: April 6, 2023

Record last verified: 2023-04

Locations

BE (2); NL (1)