Use of Muscle Ultrasound to Predict Function

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04303728
• Other study ID #: DSRB 2019/00923
• Status: Completed
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: January 30, 2022

Study information

• Verified date: April 2022
• Source: Tan Tock Seng Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Diagnostic Test:
• Muscle ultrasound
The muscle thickness and muscle quality will be assessed on ultrasound

Locations

Country	Name	City	State
Singapore	Tan Tock Seng Hospital Rehabilitation Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Independence Score	An 18-item of physical, psychological and social function (graded from 1-7)	Baseline (Performed on admission to inpatient rehabilitation)
Primary	Functional Independence Score	An 18-item of physical, psychological and social function (graded from 1-7)	Performed at 1-2 months after starting rehabilitation
Primary	Functional Independence Score	An 18-item of physical, psychological and social function (graded from 1-7)	Performed at 3-6 months
Primary	Functional Independence Score	An 18-item of physical, psychological and social function (graded from 1-7)	Performed at 1 year
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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
Primary	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	Range of motion of elbow, hip and knee	Range of motion of elbow, hip and knee	Baseline (Performed on admission to inpatient rehabilitation)
Secondary	Range of motion of elbow, hip and knee	Range of motion of elbow, hip and knee	Performed at 1-2 months after starting rehabilitation
Secondary	Range of motion of elbow, hip and knee	Range of motion of elbow, hip and knee	Performed at 3-6 months
Secondary	Range of motion of elbow, hip and knee	Range of motion of elbow, hip and knee	Performed at 1 year
Secondary	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)
Secondary	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
Secondary	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
Secondary	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