Spinal Cord Injury, AcuteMKraft_ErstrNCT03707704
Quality Control of a Strengthening Protocol in Subjects With Spinal Cord Injury
An observational study of Spinal Cord Injury, Acute, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
The aim of the master's thesis is to evaluate the clinic-internal strengthening concept of the Swiss Paraplegic Centre (SPZ). The SPZ is a rehabilitation clinic for spinal cord injured people. The strengthening concept has been routinely used since 2015. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury, Acute
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Oct 2018to 30 Nov 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with acute spinal cord injury during their initial rehabilitation
Who may be able to join
- Patients in initial rehabilitation
- SCI Level C1-C5 (ASIA Score C-D)
- SCI Lever C6-L5 (ASIA Score A-D)
- Traumatic and non-traumatic SCI
- Disease-related paraplegia, high-grade stenoses and central cord Syndromes
- Age >= 18 years
- The maximum force is tested on three predefined training devices, two devices for the upper and a device for the lower extremity. The participants will only be included in the study if they are capable of succeeding in at least both exercises for the upper extremity
Who cannot join
- Polyneuropathic diseases such as Critical Illness and Guillain Barré Syndrome
- Degenerative diseases such as multiple sclerosis and amyotrophic lateral sclerosis etc.
- Cognitive impairments
- Compliance of less than 2/3 of the training sessions
- ≥ 14 days without training
- more than 6 weeks between assessments
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official title: Quality Control of an In-hospital Strengthening Protocol in Spinal Cord Injured Subjects During Initial Rehabilitation - a Prospective Observational Study
The aim of the master's thesis is to evaluate the clinic-internal strengthening concept of the Swiss Paraplegic Centre (SPZ). The SPZ is a rehabilitation clinic for spinal cord injured people. The strengthening concept has been routinely used since 2015.
By default, the patients complete - depending on which training phase they are in - three to four strength training sessions per week. As part of the master's thesis, the development of maximum strength of patients with spinal cord injury (SCI) in primary rehabilitation will be studied. It is explicitly taken care of that the patients comply with the training requirements. Furthermore, factors which prevent a consistent buildup of strength - such as medical complications (pressure sores, pneumonia, urinary tract infections) - are systematically recorded.
The findings should provide information on the effect and qualitative transfer of the existing strength concept in everyday clinical practice. The strength training performed is accompanied by the master student and documented in a standardized manner.
- Conditions
- Spinal Cord Injury, Acute
- Keywords
- Exercise, Rehabilitation
- Medical subject headings
- Spinal Cord Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SCI patients in primary rehabilitation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-repetition-maximum as parameter for the maximum force [kg]
Calculated one-repetition-maximum based on the Brzycki equation formula
Measured: Change from 0 weeks to 5 weeks and from 5 weeks to 10 weeks
Secondary outcomes (2)
Number of completed training sessions (training compliance)
Number of completed training sessions per participant
Measured: Change from 0 weeks to 5 weeks and from 5 weeks to 10 weeks
Causes of study exclusion
Systematic documentation of exclusion causes during the participation in the study
Measured: From 0 weeks to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start10 Oct 2018
- Primary completion30 Jun 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury, AcuteStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707704
- Sponsor's protocol ID
- 2018-16
- Acronym
- MKraft_Erstr
- Status last verified
- Jan 2020
- First submitted
- 11 Oct 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Control of an In-hospital Strengthening Protocol in Spinal Cord Injured Subjects During Initial Rehabilitation - a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT03707704
- Acronym / sponsor ID
- MKraft_Erstr / 2018-16
- Conditions
- Spinal Cord Injury, Acute
- Keywords
- Exercise, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 16 Oct 2018 (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 aim of the master's thesis is to evaluate the clinic-internal strengthening concept of the Swiss Paraplegic Centre (SPZ). The SPZ is a rehabilitation clinic for spinal cord injured people. The strengthening concept has been routinely used since 2015.
By default, the patients complete - depending on which training phase they are in - three to four strength training sessions per week. As part of the master's thesis, the development of maximum strength of patients with spinal cord injury (SCI) in primary rehabilitation will be studied. It is explicitly taken care of that the patients comply with the training requirements. Furthermore, factors which prevent a consistent buildup of strength - such as medical complications (pressure sores, pneumonia, urinary tract infections) - are systematically recorded.
The findings should provide information on the effect and qualitative transfer of the existing strength concept in everyday clinical practice. The strength training performed is accompanied by the master student and documented in a standardized manner.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCI patients in primary rehabilitation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with acute spinal cord injury during their initial rehabilitation
Key inclusion criteria (7 listed)
- Patients in initial rehabilitation
- SCI Level C1-C5 (ASIA Score C-D)
- SCI Lever C6-L5 (ASIA Score A-D)
- Traumatic and non-traumatic SCI
- Disease-related paraplegia, high-grade stenoses and central cord Syndromes
Key exclusion criteria (6 listed)
- Polyneuropathic diseases such as Critical Illness and Guillain Barré Syndrome
- Degenerative diseases such as multiple sclerosis and amyotrophic lateral sclerosis etc.
- Cognitive impairments
- Compliance of less than 2/3 of the training sessions
- ≥ 14 days without training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
One-repetition-maximum as parameter for the maximum force [kg]
Time frame: Change from 0 weeks to 5 weeks and from 5 weeks to 10 weeks
Calculated one-repetition-maximum based on the Brzycki equation formula
2 secondary outcomes
Number of completed training sessions (training compliance)
Time frame: Change from 0 weeks to 5 weeks and from 5 weeks to 10 weeks
Causes of study exclusion
Time frame: From 0 weeks to 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, Acute, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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 7 inclusion and 6 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: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-repetition-maximum as parameter for the maximum force [kg] (time frame: Change from 0 weeks to 5 weeks and from 5 weeks to 10 weeks). 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 13 Jan 2020.