Clinical trial NCT05452707: Task-oriented Arm/Hand Skill Rehabilitation and Therapy Dose Dimensions in Subacute Spinal Cord Injury Rehabilitation
Official title: Task-oriented Arm/Hand Skill Rehabilitation and Therapy Dose Dimensions in Subacute Spinal Cord Injury Rehabilitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Spinal Cord Injuries
Keywords: Spinal cord rehabilitation
Therapy content in arm/hand skill training
Therapy dose in spinal cord rehabilitation
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Adelante Zorggroep
name: Universitaire Ziekenhuizen KU Leuven
name: University Ghent
First posted: 2022-07-11
Enrollment: 47
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 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:
measure: Perceived dose in spinal cord injury in the subacute rehabilitation
timeFrame: 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:
measure: Pilot study: usability of evening reports in rehabilitation of SCI.
timeFrame: 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.
Locations:
city: Gent
country: Belgium
facility: UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven - Campus Pellenberg
city: Hoensbroek
country: Netherlands
facility: Zorggroep Adelante
Study officials:
affiliation: UHasselt
name: Annemie Spooren, Prof.Dr.
role: PRINCIPAL_INVESTIGATOR
References: