MedPath

Early and intensive motor training to enhance neurological recovery and function in people with spinal cord injury

Recruiting
Conditions
Spinal Cord Injury
10041543
Registration Number
NL-OMON49919
Lead Sponsor
niversity of Sydney, Australia
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
16
Inclusion Criteria

People will be eligible to participate if they:
1. have sustained a traumatic or non-traumatic SCI below C4 (neurological
level) in the preceding 8 weeks.
2. have an AIS A lesion with motor function more than three levels below the
motor level (on one or both sides), or an AIS C or AIS D lesion (as defined by
the International Standards for the Neurological Classification of SCI).
3. are male or female, over the age of 16 years at the time of signing informed
consent
4. have been cleared by the medical team to commence rehabilitation (as
documented in the participant*s medical files).
5. are likely to remain an inpatient for the next 10 weeks.
6. understand and voluntarily sign an informed consent form prior to any study
related assessments/procedures being conducted.
7. are willing and able to adhere to the study visit schedule and other
protocol requirements.

Exclusion Criteria

People will be eligible to participate if they:
1. have sustained a traumatic or non-traumatic SCI below C4 (neurological
level) in the preceding 8 weeks.
2. have an AIS A lesion with motor function more than three levels below the
motor level (on one or both sides), or an AIS C or AIS D lesion (as defined by
the International Standards for the Neurological Classification of SCI).
3. are male or female, over the age of 16 years at the time of signing informed
consent (additional consent from a parent or guardian will be attained for
those aged under 18 years).
4. have been cleared by the medical team to commence rehabilitation (as
documented in the participant*s medical files).
5. are likely to remain an inpatient for the next 10 weeks.
6. understand and voluntarily sign an informed consent form prior to any study
related assessments/procedures being conducted.
7. are willing and able to adhere to the study visit schedule and other
protocol requirements.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Total Motor Score (/100 points) 10 weeks after randomisation</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Neurological status, Spinal Cord Independence Measure - SCIM-SR), ability to<br /><br>walk (WISCI), quality of life, participants* perceptions about ability to<br /><br>perform self-selected goals, participants* impressions of therapeutic benefit<br /><br>and time to discharge.</p><br>
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