StrokeNCT04169594
Statistical Parametric Mapping (SPM 1D) for Stroke and Trans-tibial Amputation
An observational study of Stroke and Amputation, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke, Amputation
- What is being tested?
- 3D Gait Analysis with Statistical Parametric Mapping
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- 19 Jun 2020to 5 Oct 2021
- 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 21 years and older
- All sexes
- Adult, Older adult
Study population: Patients in outpatient clinics
Who may be able to join
- 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
Show all 16Show fewer
- able to attend a single 2.5h session of research data collection.
- 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.
Who cannot join
- 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 (inability to obey 1 steps command), communication disorder precluding understanding of instructions, cognitive impairment, dementia, untreated depression or psychiatric disorder.
- End stage conditions such as medical instability or orthostatic insufficiency, organ, renal, liver, heart failure and life expectancy <6 months or on haemodialysis.
- Pregnancy.
- Local limb conditions which could be exacerbated by research interventions such as open wounds, ulcers, stump pain or stump wounds/ulcers, neuromas in amputees, active arthritis or joint or limb pain.
- Skin conditions which could be worsened by application of adhesive skin markers such as uncontrolled eczema, psoriasis, fungal or bacterial infections etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Guiding Best Practice Clinical Care With In-Silico Rehabilitation and Statistical Parametric Mapping (SPM 1D) for Unilateral Chronic Hemiparetic Stroke and Trans-tibial Amputation: An Exploratory Clinical Study
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.
Read the detailed description
This is a pilot study on the use of 3D gait analysis using motion capture in combination with Statistical Parametric Mapping in patients with unilateral hemiplegic stroke and unilateral lower limb amputation. Data collected will then be compared against a normative dataset.
The findings from this study will then be used to build a decision support tool in combination with clinical analysis which could focus clinical recommendations for gait training, physical therapy, exercise and orthotics prescription to reduce unnecessary joint forces in affected and unaffected segments.
- Conditions
- Stroke, Amputation
- Being tested
- 3D Gait Analysis with Statistical Parametric Mapping
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Gait Analysis with Statistical Parametric MappingDiagnostic test
A 3D motion capture system will be used for gait analysis. Vector field statistics will be used to simplify the clinical interpretation of time varying movement patterns.
| Study group | Role | What they receive |
|---|---|---|
| Stroke | Unilateral hemiplegic stroke patients Receives: Diagnostic Test: 3D Gait Analysis with Statistical Parametric Mapping | |
| Amputee | Unilateral transtibial amputee patients Receives: Diagnostic Test: 3D Gait Analysis with Statistical Parametric Mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body movement assessed by a motion capture system
Direction and magnitude of each body movement will be combined to provide graphical data on a motion capture system
Measured: Assessed within 1 year after patient recruitment
Secondary outcomes (3)
Fugl Meyer Assessment
Functional score for stroke patients. Minimum: 0, Maximum: 226, with higher score indicating better function
Measured: Assessed within 1 year after patient recruitment
Stroke Impact Scale
Functional score for stroke patients. Minimum:1, Maximum: 5, with higher score indicating higher impairment
Measured: Assessed within 1 year after patient recruitment
Amputee Mobility Predictor with prosthesis
Functional score for amputation patients. Minimum: 0, Maximum: 47, with higher score indicating better function.
Measured: Assessed within 1 year after patient recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start19 Jun 2020
- Primary completion5 Oct 2021
- Study completion5 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanyang Technological University
- Responsible party
- Sponsor
- Investigators
- Karen Chua, Principal investigator, Tan Tock Seng HospitalCyril Donnelly, Principal investigator, Rehabilitation Research Institute of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169594
- Sponsor's protocol ID
- DSRB_2019_99879
- Status last verified
- Oct 2021
- First submitted
- 10 Nov 2019
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guiding Best Practice Clinical Care With In-Silico Rehabilitation and Statistical Parametric Mapping (SPM 1D) for Unilateral Chronic Hemiparetic Stroke and Trans-tibial Amputation: An Exploratory Clinical Study
- ClinicalTrials.gov ID
- NCT04169594
- Acronym / sponsor ID
- DSRB_2019_99879
- Conditions
- Stroke, Amputation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Nanyang Technological University
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 5 Oct 2021 (actual)
- Study completion
- 5 Oct 2021 (actual)
- First posted
- 20 Nov 2019 (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.
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.
Detailed description
This is a pilot study on the use of 3D gait analysis using motion capture in combination with Statistical Parametric Mapping in patients with unilateral hemiplegic stroke and unilateral lower limb amputation. Data collected will then be compared against a normative dataset.
The findings from this study will then be used to build a decision support tool in combination with clinical analysis which could focus clinical recommendations for gait training, physical therapy, exercise and orthotics prescription to reduce unnecessary joint forces in affected and unaffected segments.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke | – | Diagnostic Test: 3D Gait Analysis with Statistical Parametric MappingUnilateral hemiplegic stroke patients |
| Amputee | – | Diagnostic Test: 3D Gait Analysis with Statistical Parametric MappingUnilateral transtibial amputee patients |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients in outpatient clinics
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (6 listed)
- 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 (inability to obey 1 steps command), communication disorder precluding understanding of instructions, cognitive impairment, dementia, untreated depression or psychiatric disorder.
- End stage conditions such as medical instability or orthostatic insufficiency, organ, renal, liver, heart failure and life expectancy <6 months or on haemodialysis.
- Pregnancy.
- Local limb conditions which could be exacerbated by research interventions such as open wounds, ulcers, stump pain or stump wounds/ulcers, neuromas in amputees, active arthritis or joint or limb pain.
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 |
|---|---|---|
| 3D Gait Analysis with Statistical Parametric MappingA 3D motion capture system will be used for gait analysis. Vector field statistics will be used to simplify the clinical interpretation of time varying movement patterns. | Diagnostic test | Amputee, Stroke |
Primary outcome
Body movement assessed by a motion capture system
Time frame: Assessed within 1 year after patient recruitment
Direction and magnitude of each body movement will be combined to provide graphical data on a motion capture system
3 secondary outcomes
Fugl Meyer Assessment
Time frame: Assessed within 1 year after patient recruitment
Stroke Impact Scale
Time frame: Assessed within 1 year after patient recruitment
Amputee Mobility Predictor with prosthesis
Time frame: Assessed within 1 year after patient recruitment
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 22 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Closed-Loop SCS-BCI for Post-Stroke Hemiplegia
Stroke, Motor Dysfunction
Active, not recruiting
Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
Stroke, Cognitive Dysfunction
Not yet recruitingObservational study
A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients
Stroke Patients, Tracheostomy
RecruitingPhase 4
Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
Cerebrovascular Disorders
Not yet recruiting
Effect of Early Tendon Vibrations on Upper Limb Motor Recovery After a Stroke
Acute Stroke, Upper Limb Motor Deficit
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.
Karen Chua principal investigator
Tan Tock Seng Hospital
Cyril Donnelly principal investigator
Rehabilitation Research Institute of Singapore
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 Stroke and Amputation, run by Tan Tock Seng Hospital at 1 site in Singapore.
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 16 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 22 Oct 2021. 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 Singapore. 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?
Body movement assessed by a motion capture system (time frame: Assessed within 1 year after patient recruitment). 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 22 Oct 2021.