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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05452707
• Other study ID #: NB1
• Status: Recruiting
• Start date: July 11, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: April 2023
• Source: Hasselt University
• Contact: Annemie Spooren, Prof. Dr.
• Phone: +32 11 26 93 32
• Email: annemie.spooren[@]uhasselt.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 47
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• Observation and questionnaire of active therapy
There will be an observation of the usual care; no intervention will be added.

Locations

Country	Name	City	State
Belgium	UZ Gent	Gent
Belgium	UZ Leuven - Campus Pellenberg	Leuven
Netherlands	Zorggroep Adelante	Hoensbroek

Sponsors (4)

Lead Sponsor	Collaborator
Hasselt University	Adelante Zorggroep, Universitaire Ziekenhuizen KU Leuven, University Ghent

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	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	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.