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Use of Muscle Ultrasound to Predict Function

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04303728
Enrollment
80
Registered
2020-03-11
Start date
2020-02-01
Completion date
2022-01-30
Last updated
2022-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury

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.

Interventions

DIAGNOSTIC_TESTMuscle ultrasound

The muscle thickness and muscle quality will be assessed on ultrasound

Sponsors

Tan Tock Seng Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Functional Independence ScoreBaseline (Performed on admission to inpatient rehabilitation)An 18-item of physical, psychological and social function (graded from 1-7)
Spinal Cord Independence Measure (SCIM) IIIBaseline (Performed on admission to inpatient rehabilitation)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.
ASIA scoreBaseline (Performed on admission to inpatient rehabilitation)This is an assessor administered test that systematically examines the dermatomes and myotomes in spinal cord patients through testing the strength and sensation
Walking Index for Spinal Cord Injury II (WISCI II)Baseline (Performed on admission to inpatient rehabilitation)A walking scale used by health care practitioners to grade the walking ability of SCI patients.

Secondary

MeasureTime frameDescription
Range of motion of elbow, hip and kneeBaseline (Performed on admission to inpatient rehabilitation)Range of motion of elbow, hip and knee
SpasticityBaseline (Performed on admission to inpatient rehabilitation)(2) Spasticity of the elbow flexors, knee extensors and ankle plantarflexors using the Modified Ashworth Scale, with a higher score indicating worse spasticity

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026