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Statistical Parametric Mapping (SPM 1D) for Stroke and Trans-tibial Amputation

NCT ID: NCT04169594

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-19

Study Completion Date

2021-10-05

Brief Summary

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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

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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

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Stroke Amputation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Stroke

Unilateral hemiplegic stroke patients

3D Gait Analysis with Statistical Parametric Mapping

Intervention Type DIAGNOSTIC_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.

Amputee

Unilateral transtibial amputee patients

3D Gait Analysis with Statistical Parametric Mapping

Intervention Type DIAGNOSTIC_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.

Interventions

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3D Gait Analysis with Statistical Parametric Mapping

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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.


* 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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanyang Technological University

OTHER

Sponsor Role collaborator

Tan Tock Seng Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Chua

Role: PRINCIPAL_INVESTIGATOR

Tan Tock Seng Hospital

Cyril Donnelly

Role: PRINCIPAL_INVESTIGATOR

Rehabilitation Research Institute of Singapore

Locations

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Tan Tock Seng Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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DSRB_2019_99879

Identifier Type: -

Identifier Source: org_study_id