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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Amputation
• Intervention / Treatment: Diagnostic test: 3D Gait Analysis with Statistical Parametric Mapping

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 Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • Tan Tock Seng Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients in outpatient clinics

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Stroke; Unilateral hemiplegic stroke patients	Diagnostic test: 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.
Amputee; Unilateral transtibial amputee patients	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Assessed within 1 year after patient recruitment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl Meyer Assessment	Functional score for stroke patients. Minimum: 0, Maximum: 226, with higher score indicating better function	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	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.	Assessed within 1 year after patient recruitment

Collaborators and Investigators

• Sponsor: Tan Tock Seng Hospital
• Collaborators: Nanyang Technological University
• Investigators: Principal Investigator: Karen Chua, Tan Tock Seng Hospital; Principal Investigator: Cyril Donnelly, Rehabilitation Research Institute of Singapore

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2020
• Primary Completion (Actual): October 5, 2021
• Study Completion (Actual): October 5, 2021

Study Registration Dates

• First Submitted: November 10, 2019
• First Submitted That Met QC Criteria: November 17, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: DSRB_2019_99879

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No