Clinical trial NCT04169594: Statistical Parametric Mapping (SPM 1D) for Stroke and Trans-tibial Amputation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Amputation
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
Collaborators: name: Nanyang Technological University
First posted: 2019-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in outpatient clinics

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.

Eligibility criteria: 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 (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.

Primary outcomes:
measure: Body movement assessed by a motion capture system
timeFrame: Assessed within 1 year after patient recruitment
Secondary outcomes:
measure: Fugl Meyer Assessment
timeFrame: Assessed within 1 year after patient recruitment
measure: Stroke Impact Scale
timeFrame: Assessed within 1 year after patient recruitment
measure: Amputee Mobility Predictor with prosthesis
timeFrame: Assessed within 1 year after patient recruitment
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Karen Chua
role: PRINCIPAL_INVESTIGATOR
affiliation: Rehabilitation Research Institute of Singapore
name: Cyril Donnelly
role: PRINCIPAL_INVESTIGATOR
References: