Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580990
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Neck-specific Exercises Effectively Improves Whiplash-associated Disorders
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of a Telerehabilitation Programme Based on Specific Neck Specific Neck Exercises in Patients with Whiplash-associated Disorders Randomised Clinical Trial Controlled
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Whiplash-associated disorders WAD are common injuries from motor vehicle accidents typically treated with a return to normal activity and neck exercises The Spinetrack device has been approved for deep neck musculature training but its impact on pain and disability in subacute WAD patients in a virtual setting hasnt been evaluated yet This study aims to assess the effect of a telerehabilitation programme using the Spinetrack device on pain and self-perceived disability in subacute WAD I and II patients The single-blinded randomised controlled clinical trial will involve 102 participants divided into three groups a telerehabilitation group using Spinetrack a group with a standard telerehabilitation programme and a usual care group Training will be conducted via video call for six weeks The study expects to confirm that deep neck musculature training reduces pain and disability in WAD patients and establish Spinetrack as an efficient tool for subacute WAD treatment
Detailed Description:
Introduction Whiplash-associated disorders WAD are a group of clinical manifestations experienced by individuals following a sudden acceleration-deceleration mechanism of the neck WAD are the most common injuries resulting from a motor vehicle accident The mainstays of WAD treatment are a return to normal activity and both general and deep neck musculature exercises Recently a device called Spinetrack has been validated to facilitate training of the deep craniocervical musculature This device can even be adapted for use in a virtual format However to date it has not been determined how this device contributes to the improvement of pain and disability in individuals with subacute WAD in a virtual context
Objective The aim of this study is to evaluate the effect of a telerehabilitation programme which is based on specific neck exercises with the Spinetrack on pain and self-perceived disability in people with WAD I and II in the subacute stage
Methods This study is a single-blinded randomised controlled clinical trial A total of 102 subjects with WAD I and II will be recruited according to the Quebec Task Force classification in the subacute stage The participants will be randomised into three groups a telerehabilitation group based on specific neck exercises with the Spinetrack SES a treatment group with a telerehabilitation programme with standard specific neck exercises SSE and a usual care group UCG
Training will be carried out via video call over 12 sessions distributed over six weeks with two sessions per week The main outcome variables will be pain and perceived disability
Expected Results The investigators anticipate that training the deep neck musculature will reduce pain and disability in patients with WAD It is expected to demonstrate the devices function as a tool for self-management of neck symptoms and to provide the health care system with an efficient device for the treatment of subacute WAD
Objective The aim of this study is to evaluate the effect of a telerehabilitation programme which is based on specific neck exercises with the Spinetrack on pain and self-perceived disability in people with WAD I and II in the subacute stage
Methods This study is a single-blinded randomised controlled clinical trial A total of 102 subjects with WAD I and II will be recruited according to the Quebec Task Force classification in the subacute stage The participants will be randomised into three groups a telerehabilitation group based on specific neck exercises with the Spinetrack SES a treatment group with a telerehabilitation programme with standard specific neck exercises SSE and a usual care group UCG
Training will be carried out via video call over 12 sessions distributed over six weeks with two sessions per week The main outcome variables will be pain and perceived disability
Expected Results The investigators anticipate that training the deep neck musculature will reduce pain and disability in patients with WAD It is expected to demonstrate the devices function as a tool for self-management of neck symptoms and to provide the health care system with an efficient device for the treatment of subacute WAD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None