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

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: Observation and questionnaire of active therapy

• Study Type: Observational
• Enrollment (Anticipated): 47

Contacts and Locations

• Study Contact: Name: Annemie Spooren, Prof. Dr.; Phone Number: +32 11 26 93 32; Email: annemie.spooren@uhasselt.be
• Study Contact Backup: Name: Nele Bertels, MSC; Phone Number: +32 11 26 86 92; Email: nele.bertels@uhasselt.be

Study Locations

• Belgium
  • Gent, Belgium
    • Recruiting
    • UZ Gent
  • Leuven, Belgium
    • Recruiting
    • UZ Leuven - Campus Pellenberg
• Netherlands
  • Hoensbroek, Netherlands
    • Recruiting
    • Zorggroep Adelante

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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	Other: Observation and questionnaire of active therapy; There will be an observation of the usual care; no intervention will be added.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived dose in spinal cord injury in the subacute rehabilitation	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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pilot study: usability of evening reports in rehabilitation of SCI.	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	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.

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Universitaire Ziekenhuizen KU Leuven; University Ghent; Adelante Zorggroep
• Investigators: Principal Investigator: Annemie Spooren, Prof.Dr., UHasselt

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: April 6, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 4, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Spinal cord rehabilitation; Therapy content in arm/hand skill training; Therapy dose in spinal cord rehabilitation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: NB1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No