Use of Muscle Ultrasound to Predict Function

Not Applicable

Completed

• Conditions: Spinal Cord Injury
• Interventions: Diagnostic Test: Muscle ultrasound

• Registration Number: NCT04303728
• Lead Sponsor: Tan Tock Seng Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-01-29
• Study Start: 2020-02-01
• Study First Submitted QC: 2020-03-09
• Study First Posted: 2020-03-11
• Primary Completion: 2022-01-30
• Study Completion: 2022-01-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-26
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Muscle ultrasound	Muscle ultrasound	Muscle ultrasound will be performed for the patient on admission and at 1-2 months from inpatient rehabilitation.

Primary Outcome Measures

Name	Time	Method
Spinal Cord Independence Measure (SCIM) III	Performed at 1 year	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.
Walking Index for Spinal Cord Injury II (WISCI II)	Performed on 1 year	A walking scale used by health care practitioners to grade the walking ability of SCI patients.
Functional Independence Score	Performed at 1 year	An 18-item of physical, psychological and social function (graded from 1-7)
ASIA score	Performed at 1 year	This is an assessor administered test that systematically examines the dermatomes and myotomes in spinal cord patients through testing the strength and sensation

Secondary Outcome Measures

Name	Time	Method
Range of motion of elbow, hip and knee	Performed at 1 year	Range of motion of elbow, hip and knee
Spasticity	Performed at 1 year	(2) Spasticity of the elbow flexors, knee extensors and ankle plantarflexors using the Modified Ashworth Scale, with a higher score indicating worse spasticity

Trial Locations

Locations (1)

Tan Tock Seng Hospital Rehabilitation Centre; 🇸🇬 Singapore, Singapore