Gait Disorders, NeurologicNCT03343132
Gait Adaptability: Tracking Locomotor Recovery After Incomplete Spinal Cord Injury
An observational study of Gait Disorders, Neurologic and Gait Disorder, Sensorimotor, run by University of Zurich at 1 site in Switzerland.
Trial summary
Adaptive gait assessements will be evaluated as a potential new marker for tracking locomotor recovery throughout rehabilitation of spinal cord injury subjects. To this end, controls, subacute and chronic patients will be assessed at two timepoints with 3 month standard rehabilitation inbetween. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gait Disorders, Neurologic, Gait Disorder, Sensorimotor
- What is being tested?
- Standard locomotor therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 98 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2018to 2 Sep 2022
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic; community sample
Who may be able to join
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Healthy controls
- Patients with an incomplete spinal cord injury in a chronic (at least 12 months post-injury) or subacute (3-6 months post-injury) stage of recovery
- Age: 18 years and older
- Able to stand without physical assistance and handrails for more than 120s
- preserved segmental and cutaneo-muscular reflexes in the lower limbs
- Bodyweight over 20 kg and under 120 kg
- Mini-Mental state examination score 26 (test only performed if cognitive deficits are suspected)
Who cannot join
- Current orthopedic problems
- Neurological impairment other than SCI
- Premorbid major depression or psychosis
- Metal implants in the cervical skull
- History of significant autonomic dysreflexia with treatment
- Dermatological issues (e.g. decubitus) at the harness attachment site (back, abdomen, upper legs)
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- Malignant diseases
- Heart insufficiency NYHA III-IV
- Potential pregnancy
- Unlikely to complete the intervention or return for follow-up
- Participation in another training study
- Contraindications for training using the GRAIL (according the manual)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gait Adaptability: Tracking Locomotor Recovery After Incomplete Spinal Cord Injury Via Sensitive Assessments in a Virtual Reality Treadmill Environment
Adaptive gait assessements will be evaluated as a potential new marker for tracking locomotor recovery throughout rehabilitation of spinal cord injury subjects. To this end, controls, subacute and chronic patients will be assessed at two timepoints with 3 month standard rehabilitation inbetween. The specific assessments will require the participant to acitvely modulate their gait pattern to fullfill specific task constraints. Their performance will be assessed via 3D kinematics, kinetics and EMG and these measures will be used to describe the adaptive capacity that the patient retains. Sensitivity and specificity of these markers will be determined. With more sensitive descriptors of gait function and quality, locomotor rehabilitation for SCI can be better designed and smaller effects can be accurately measured.
- Being tested
- Standard locomotor therapy
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard locomotor therapyBehavioural
Typical clinical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Subacute SCI | Not described Receives: Behavioral: Standard locomotor therapy | |
| Chronic SCI | Not described | |
| Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in kinematics
Recording of movement tasks
Measured: Baseline and through study completion, an average of 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Jan 2018
- Primary completion2 Sep 2022
- Study completion2 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gait Disorders, NeurologicStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation Wings For Life
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343132
- Sponsor's protocol ID
- 2017-01780
- Other IDs
- 2017
- Status last verified
- Aug 2022
- First submitted
- 9 Oct 2017
- Last updated
- 7 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zipser-Mohammadzada F, Scheffers MF, Conway BA, Halliday DM, Zipser CM, Curt A, Schubert M. Intramuscular coherence enables robust assessment of modulated supra-spinal input in human gait: an inter-dependence study of visual task and walking speed. Exp Brain Res. 2023 Jun;241(6):1675-1689. doi: 10.1007/s00221-023-06635-4. Epub 2023 May 18.
PubMed 37199775Mohammadzada F, Zipser CM, Easthope CA, Halliday DM, Conway BA, Curt A, Schubert M. Mind your step: Target walking task reveals gait disturbance in individuals with incomplete spinal cord injury. J Neuroeng Rehabil. 2022 Mar 25;19(1):36. doi: 10.1186/s12984-022-01013-7.
PubMed 35337335
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Adaptability: Tracking Locomotor Recovery After Incomplete Spinal Cord Injury Via Sensitive Assessments in a Virtual Reality Treadmill Environment
- ClinicalTrials.gov ID
- NCT03343132
- Acronym / sponsor ID
- 2017-01780
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Foundation Wings For Life
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 2 Sep 2022 (actual)
- Study completion
- 2 Sep 2022 (actual)
- First posted
- 17 Nov 2017 (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.
Adaptive gait assessements will be evaluated as a potential new marker for tracking locomotor recovery throughout rehabilitation of spinal cord injury subjects. To this end, controls, subacute and chronic patients will be assessed at two timepoints with 3 month standard rehabilitation inbetween. The specific assessments will require the participant to acitvely modulate their gait pattern to fullfill specific task constraints. Their performance will be assessed via 3D kinematics, kinetics and EMG and these measures will be used to describe the adaptive capacity that the patient retains. Sensitivity and specificity of these markers will be determined. With more sensitive descriptors of gait function and quality, locomotor rehabilitation for SCI can be better designed and smaller effects can be accurately measured.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subacute SCI | – | Behavioral: Standard locomotor therapy |
| Chronic SCI | – | – |
| Controls | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic; community sample
Key inclusion criteria (8 listed)
- Informed Consent as documented by signature (Appendix Informed Consent Form)
- Healthy controls
- Patients with an incomplete spinal cord injury in a chronic (at least 12 months post-injury) or subacute (3-6 months post-injury) stage of recovery
- Age: 18 years and older
- Able to stand without physical assistance and handrails for more than 120s
Key exclusion criteria (12 listed)
- Current orthopedic problems
- Neurological impairment other than SCI
- Premorbid major depression or psychosis
- Metal implants in the cervical skull
- History of significant autonomic dysreflexia with treatment
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 |
|---|---|---|
| Standard locomotor therapyTypical clinical therapy. | Behavioural | Subacute SCI |
Primary outcome
Change in kinematics
Time frame: Baseline and through study completion, an average of 4 months
Recording of movement tasks
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 7 Sep 2022.
- Derived from this study: PubMed 37199775Zipser-Mohammadzada F, Scheffers MF, Conway BA, Halliday DM, Zipser CM, Curt A, Schubert M. Intramuscular coherence enables robust assessment of modulated supra-spinal input in human gait: an inter-dependence study of visual task and walking speed. Exp Brain Res. 2023 Jun;241(6):1675-1689. doi: 10.1007/s00221-023-06635-4. Epub 2023 May 18.
- Derived from this study: PubMed 35337335Mohammadzada F, Zipser CM, Easthope CA, Halliday DM, Conway BA, Curt A, Schubert M. Mind your step: Target walking task reveals gait disturbance in individuals with incomplete spinal cord injury. J Neuroeng Rehabil. 2022 Mar 25;19(1):36. doi: 10.1186/s12984-022-01013-7.
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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 Gait Disorders, Neurologic and Gait Disorder, Sensorimotor, run by University of Zurich 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 8 inclusion and 12 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 7 Sep 2022. 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?
Change in kinematics (time frame: Baseline and through study completion, an average of 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03343132, which also lists 2 linked publications.
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 7 Sep 2022.