Statistical Parametric Mapping (SPM 1D) for Stroke and Trans-tibial Amputation
- Conditions
- AmputationStroke
- Interventions
- Diagnostic Test: 3D Gait Analysis with Statistical Parametric Mapping
- Registration Number
- NCT04169594
- Lead Sponsor
- Tan Tock Seng Hospital
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Stroke 3D Gait Analysis with Statistical Parametric Mapping Unilateral hemiplegic stroke patients Amputee 3D Gait Analysis with Statistical Parametric Mapping Unilateral transtibial amputee patients
- Primary Outcome Measures
Name Time Method Body movement assessed by a motion capture system 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
- Secondary Outcome Measures
Name Time Method Stroke Impact Scale Assessed within 1 year after patient recruitment Functional score for stroke patients. Minimum:1, Maximum: 5, with higher score indicating higher impairment
Amputee Mobility Predictor with prosthesis Assessed within 1 year after patient recruitment Functional score for amputation patients. Minimum: 0, Maximum: 47, with higher score indicating better function.
Fugl Meyer Assessment Assessed within 1 year after patient recruitment Functional score for stroke patients. Minimum: 0, Maximum: 226, with higher score indicating better function
Trial Locations
- Locations (1)
Tan Tock Seng Hospital
🇸🇬Singapore, Singapore