Clinical trial NCT04303728: Use of Muscle Ultrasound to Predict Function
Official title: Muscle Ultrasound as a Predictor of Functional Status in Spinal Cord Injury Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional Independence Score
timeFrame: Baseline (Performed on admission to inpatient rehabilitation)
measure: Functional Independence Score
timeFrame: Performed at 1-2 months after starting rehabilitation
measure: Functional Independence Score
timeFrame: Performed at 3-6 months
measure: Functional Independence Score
timeFrame: Performed at 1 year
measure: Spinal Cord Independence Measure (SCIM) III
timeFrame: Baseline (Performed on admission to inpatient rehabilitation)
measure: Spinal Cord Independence Measure (SCIM) III
timeFrame: Performed at 1-2 months after starting rehabilitation
measure: Spinal Cord Independence Measure (SCIM) III
timeFrame: Performed at 3-6 months
measure: Spinal Cord Independence Measure (SCIM) III
timeFrame: Performed at 1 year
measure: ASIA score
timeFrame: Baseline (Performed on admission to inpatient rehabilitation)
measure: ASIA score
timeFrame: Performed at 1-2 months after starting rehabilitation
measure: ASIA score
timeFrame: Performed at 3-6 months
measure: ASIA score
timeFrame: Performed at 1 year
measure: Walking Index for Spinal Cord Injury II (WISCI II)
timeFrame: Baseline (Performed on admission to inpatient rehabilitation)
measure: Walking Index for Spinal Cord Injury II (WISCI II)
timeFrame: Performed at 1-2 months after starting rehabilitation
measure: Walking Index for Spinal Cord Injury II (WISCI II)
timeFrame: Performed on 3-6 months
measure: Walking Index for Spinal Cord Injury II (WISCI II)
timeFrame: Performed on 1 year
Secondary outcomes:
measure: Range of motion of elbow, hip and knee
timeFrame: Baseline (Performed on admission to inpatient rehabilitation)
measure: Range of motion of elbow, hip and knee
timeFrame: Performed at 1-2 months after starting rehabilitation
measure: Range of motion of elbow, hip and knee
timeFrame: Performed at 3-6 months
measure: Range of motion of elbow, hip and knee
timeFrame: Performed at 1 year
measure: Spasticity
timeFrame: Baseline (Performed on admission to inpatient rehabilitation)
measure: Spasticity
timeFrame: Performed at 1-2 months after starting rehabilitation
measure: Spasticity
timeFrame: Performed at 3-6 months
measure: Spasticity
timeFrame: Performed at 1 year
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital Rehabilitation Centre
Study officials:
affiliation: Tan Tock Seng Hospital
name: Matthew Tay, MD
role: PRINCIPAL_INVESTIGATOR
References: