Use of Muscle Ultrasound to Predict Function

Study Overview
=================
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.

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

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Diagnostic Test: Muscle ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First ever acute SCI Age 21-65 years Presence of weakness in the lower limbs (defined as either ASIA A, B, C or D) Independent in ambulation prior to onset of SCI Able to understand study procedures and sign informed consent Clinical suitability for rehabilitation Exclusion Criteria: Presence of premorbid lower musculoskeletal conditions eg contractures, fractures, previous operations, that prevents proper ultrasound assessment of the affected limb Cardiorespiratory conditions eg congestive cardiac failure (EF<40%), chronic arrhythmias, COPD stage 3-4 End stage illness, end stage renal failure, life expectancy <6 months Other active neurological conditions Botulinum toxin injection over the past 3 months

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Muscle ultrasound<br>Muscle ultrasound will be performed for the patient on admission and at 1-2 months from inpatient rehabilitation. | Diagnostic Test: Muscle ultrasound<br>* The muscle thickness and muscle quality will be assessed on ultrasound<br>|

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 |