Spinal Cord InjuriesNCT05452707
Task-oriented Arm/Hand Skill Rehabilitation and Therapy Dose Dimensions in Subacute Spinal Cord Injury Rehabilitation
An observational study of Spinal Cord Injuries, run by Hasselt University at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Observation and questionnaire of active therapy
- How many people
- 47 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 11 Jul 2022to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
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- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Belgium2 sites, 2 recruiting
- Recruiting
UZ Gent
Ghent
- Recruiting
UZ Leuven - Campus Pellenberg
Leuven
About this study
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
- Being tested
- Observation and questionnaire of active therapy
- Keywords
- Spinal cord rehabilitation, Therapy content in arm/hand skill training, Therapy dose in spinal cord rehabilitation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation and questionnaire of active therapyOther
There will be an observation of the usual care; no intervention will be added.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Observation and questionnaire of active therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start11 Jul 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Adelante Zorggroep, Universitaire Ziekenhuizen KU Leuven, University Ghent
- Responsible party
- Principal investigator, Annemie Spooren, Hasselt University
- Investigators
- Annemie Spooren, Prof.Dr., Principal investigator, UHasselt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452707
- Sponsor's protocol ID
- NB1
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2022
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task-oriented Arm/Hand Skill Rehabilitation and Therapy Dose Dimensions in Subacute Spinal Cord Injury Rehabilitation
- ClinicalTrials.gov ID
- NCT05452707
- Acronym / sponsor ID
- NB1
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal cord rehabilitation, Therapy content in arm/hand skill training, Therapy dose in spinal cord rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Adelante Zorggroep, Universitaire Ziekenhuizen KU Leuven, University Ghent
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Observation and questionnaire of active therapyPatients will be observed during their active training sessions. Patients will be asked questions about: * fatigue * physical fatigue * pain * the difficulty of the session * motivation |
| Therapists | – | Other: Observation and questionnaire of active therapyTherapists 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 |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- Primary objective
- Secondary objective
- Persons with SCI (C1-S4)
- having an AIS A, B, C, D;
- Are older than 16 years;
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation and questionnaire of active therapyThere will be an observation of the usual care; no intervention will be added. | Other | Patients, Therapists |
Primary outcome
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
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annemie Spooren, Prof.Dr. principal investigator
UHasselt
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by Hasselt University at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annemie Spooren, Prof. Dr. (+32 11 26 93 32, annemie.spooren@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.