Use of Muscle Ultrasound to Predict Function

Muscle Ultrasound as a Predictor of Functional Status in Spinal Cord Injury Patients

Establish if change from the baseline in ultrasound muscle parameters over 2 months of rehabilitation correlates with functional status of SCI patients at the end of rehabilitation

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injury
• Intervention / Treatment: Diagnostic test: Muscle ultrasound

Detailed Description

Rehabilitation is the key to ambulatory recovery in patients with spinal cord injury, although only 25% of patients regain this ability despite current rehabilitation protocols. There is emerging evidence that intensive and prolonged rehabilitation, though costly and manpower intensive, may result in ambulatory recovery in patients previously thought to be non-ambulant. However, there are no suitable clinical biomarkers which can identify these group of patients who will benefit from this intervention.

Hence the aim is to establish if change from the baseline in ultrasound muscle parameters over rehabilitation correlates with functional status of SCI patients.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 569766
    • Tan Tock Seng Hospital Rehabilitation Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. First ever acute SCI
2. Age 21-65 years
3. Presence of weakness in the lower limbs (defined as either ASIA A, B, C or D)
4. Independent in ambulation prior to onset of SCI
5. Able to understand study procedures and sign informed consent
6. Clinical suitability for rehabilitation

Exclusion Criteria:

1. Presence of premorbid lower musculoskeletal conditions eg contractures, fractures, previous operations, that prevents proper ultrasound assessment of the affected limb
2. Cardiorespiratory conditions eg congestive cardiac failure (EF<40%), chronic arrhythmias, COPD stage 3-4
3. End stage illness, end stage renal failure, life expectancy <6 months
4. Other active neurological conditions
5. Botulinum toxin injection over the past 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Muscle ultrasound; Muscle ultrasound will be performed for the patient on admission and at 1-2 months from inpatient rehabilitation.	Diagnostic test: Muscle ultrasound; The muscle thickness and muscle quality will be assessed on ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Independence Score	An 18-item of physical, psychological and social function (graded from 1-7)	Baseline (Performed on admission to inpatient rehabilitation)
Functional Independence Score	An 18-item of physical, psychological and social function (graded from 1-7)	Performed at 1-2 months after starting rehabilitation
Functional Independence Score	An 18-item of physical, psychological and social function (graded from 1-7)	Performed at 3-6 months
Functional Independence Score	An 18-item of physical, psychological and social function (graded from 1-7)	Performed at 1 year
Spinal Cord Independence Measure (SCIM) III	It is used by health care practitioners to assess and grade the functional status of a person based on the level of assistance he or she requires, in patients with spinal cord injury. Only the patient's indoor mobility subscore will be assessed from abilities, graded from 0-8.	Baseline (Performed on admission to inpatient rehabilitation)
Spinal Cord Independence Measure (SCIM) III	It is used by health care practitioners to assess and grade the functional status of a person based on the level of assistance he or she requires, in patients with spinal cord injury. Only the patient's indoor mobility subscore will be assessed from abilities, graded from 0-8.	Performed at 1-2 months after starting rehabilitation
Spinal Cord Independence Measure (SCIM) III	It is used by health care practitioners to assess and grade the functional status of a person based on the level of assistance he or she requires, in patients with spinal cord injury. Only the patient's indoor mobility subscore will be assessed from abilities, graded from 0-8.	Performed at 3-6 months
Spinal Cord Independence Measure (SCIM) III	It is used by health care practitioners to assess and grade the functional status of a person based on the level of assistance he or she requires, in patients with spinal cord injury. Only the patient's indoor mobility subscore will be assessed from abilities, graded from 0-8.	Performed at 1 year
ASIA score	This is an assessor administered test that systematically examines the dermatomes and myotomes in spinal cord patients through testing the strength and sensation	Baseline (Performed on admission to inpatient rehabilitation)
ASIA score	This is an assessor administered test that systematically examines the dermatomes and myotomes in spinal cord patients through testing the strength and sensation	Performed at 1-2 months after starting rehabilitation
ASIA score	This is an assessor administered test that systematically examines the dermatomes and myotomes in spinal cord patients through testing the strength and sensation	Performed at 3-6 months
ASIA score	This is an assessor administered test that systematically examines the dermatomes and myotomes in spinal cord patients through testing the strength and sensation	Performed at 1 year
Walking Index for Spinal Cord Injury II (WISCI II)	A walking scale used by health care practitioners to grade the walking ability of SCI patients.	Baseline (Performed on admission to inpatient rehabilitation)
Walking Index for Spinal Cord Injury II (WISCI II)	A walking scale used by health care practitioners to grade the walking ability of SCI patients.	Performed at 1-2 months after starting rehabilitation
Walking Index for Spinal Cord Injury II (WISCI II)	A walking scale used by health care practitioners to grade the walking ability of SCI patients.	Performed on 3-6 months
Walking Index for Spinal Cord Injury II (WISCI II)	A walking scale used by health care practitioners to grade the walking ability of SCI patients.	Performed on 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of motion of elbow, hip and knee	Range of motion of elbow, hip and knee	Baseline (Performed on admission to inpatient rehabilitation)
Range of motion of elbow, hip and knee	Range of motion of elbow, hip and knee	Performed at 1-2 months after starting rehabilitation
Range of motion of elbow, hip and knee	Range of motion of elbow, hip and knee	Performed at 3-6 months
Range of motion of elbow, hip and knee	Range of motion of elbow, hip and knee	Performed at 1 year
Spasticity	(2) Spasticity of the elbow flexors, knee extensors and ankle plantarflexors using the Modified Ashworth Scale, with a higher score indicating worse spasticity	Baseline (Performed on admission to inpatient rehabilitation)
Spasticity	(2) Spasticity of the elbow flexors, knee extensors and ankle plantarflexors using the Modified Ashworth Scale, with a higher score indicating worse spasticity	Performed at 1-2 months after starting rehabilitation
Spasticity	(2) Spasticity of the elbow flexors, knee extensors and ankle plantarflexors using the Modified Ashworth Scale, with a higher score indicating worse spasticity	Performed at 3-6 months
Spasticity	(2) Spasticity of the elbow flexors, knee extensors and ankle plantarflexors using the Modified Ashworth Scale, with a higher score indicating worse spasticity	Performed at 1 year

Collaborators and Investigators

• Sponsor: Tan Tock Seng Hospital
• Investigators: Principal Investigator: Matthew Tay, MD, Tan Tock Seng Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2020
• Primary Completion (ACTUAL): January 30, 2022
• Study Completion (ACTUAL): January 30, 2022

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (ACTUAL): March 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: DSRB 2019/00923

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