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

• ClinicalTrials.gov Identifier: NCT05452707
• Recruitment Status: Recruiting
• First Posted: July 11, 2022
• Last Update Posted: April 6, 2023
• Sponsor: Hasselt University
• Collaborators: Adelante Zorggroep; Universitaire Ziekenhuizen KU Leuven; University Ghent
• Information provided by (Responsible Party): Annemie Spooren, Hasselt University

Study Description

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.

Condition or disease	Intervention/treatment
Spinal Cord Injuries	Other: Observation and questionnaire of active therapy

Study Design

• Study Type: Observational
• Estimated Enrollment: 47 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Task-oriented Arm/Hand Skill Rehabilitation and Therapy Dose Dimensions in Subacute Spinal Cord Injury Rehabilitation
• Actual Study Start Date: July 11, 2022
• Estimated Primary Completion Date: September 1, 2023
• Estimated Study Completion Date: September 1, 2023

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: 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 ]
   • 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 Outcome Measures :

1. Perceived dose in spinal cord injury in the subacute rehabilitation [ Time Frame: 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. ]

   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 Outcome Measures:

1. Pilot study: usability of evening reports in rehabilitation of SCI. [ Time Frame: 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

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Annemie Spooren, Prof. Dr.; +32 11 26 93 32; annemie.spooren@uhasselt.be

Contact: Nele Bertels, MSC; +32 11 26 86 92; nele.bertels@uhasselt.be

Locations

Belgium

UZ Gent; Recruiting

Gent, Belgium

UZ Leuven - Campus Pellenberg; Recruiting

Leuven, Belgium

Netherlands

Zorggroep Adelante; Recruiting

Hoensbroek, Netherlands

Sponsors and Collaborators

Hasselt University

Adelante Zorggroep

Universitaire Ziekenhuizen KU Leuven

University Ghent

Investigators

• Principal Investigator: Annemie Spooren, Prof.Dr.; UHasselt

More Information

• Responsible Party: Annemie Spooren, Principal Investigator, Hasselt University
• ClinicalTrials.gov Identifier: NCT05452707
• Other Study ID Numbers: NB1
• First Posted: July 11, 2022
• Last Update Posted: April 6, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Annemie Spooren, Hasselt University:

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

Additional relevant MeSH terms:

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