Statistical Parametric Mapping (SPM 1D) for Stroke and Trans-tibial Amputation (NCT04169594) | Clinical Trial Compass
CompletedNot Applicable
Statistical Parametric Mapping (SPM 1D) for Stroke and Trans-tibial Amputation
Singapore30 participantsStarted 2020-06-19
Plain-language summary
Gait analysis is commonly performed in clinical practice. However, it is complex and requires an understanding of the activation of muscles in lower limbs, trunk, and upper limbs in a specific spatiotemporal pattern and the appropriate joint positions which support and advance the body weight in different phases of gait cycles.
In study, we plan to pilot the application of 3D gait analysis with statistical modelling in 2 common causes of gait deviation: unilateral hemiplegic stroke and unilateral lower limb amputation.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria for stroke patients:
* First ever chronic unilateral hemiparetic stroke subjects, with stroke diagnosed by a physician and confirmed via CT/MRI
* \>6 months post stroke
* ambulant with at most contact guard/standby supervision with/without walking aid during the study
* 10m Walk Test \>/=0.2m/s and 6min Walking test walking distance of \>/=50m without rest stop, with Functional Ambulation Category of \>/=4 ((Holden et al, 1994)
* AMT\>6
* able to understand study procedures and sign informed consent
* able to attend a single 2.5h session of research data collection.
Inclusion Criteria for amputee patients:
* First ever chronic unilateral transtibial amputee subjects
* intact residual limb
* \> 6 months post amputation
* ambulant with at most contact guard/standby supervision with/without walking aid during the study
* 10m Walk Test \>/=0.2m/s and 6min Walking test walking distance of \>/=50m without rest stop
* with Medicare K level of \>1
* AMT\>6
* able to understand study procedures and sign informed consent
* able to attend a single 2.5h session of research data collection.
Exclusion Criteria:
* Unstable recent cardiorespiratory conditions including uncontrolled hypertension/ hypotension, angina pectoris, myocardial infarction, active congestive cardiac failure, untreated cardiac arrhythmias (e.g. atrial fibrillation), untreated pulmonary embolism or deep vein thrombosis, presence of cardiac pacemaker.
* Functional status: severe aphasia or neglect…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Body movement assessed by a motion capture system
Timeframe: Assessed within 1 year after patient recruitment