Rehabilitation for Whiplash Associated Disorders

NCT05319808 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2023-12-08

No results posted yet for this study

Summary

Individuals (n=180) with subacute (\<1 month, \>3 months) WAD grade I and II with medium to high-risk symptoms of working age will be randomized into three groups with block randomization in a prospective, assessor-blinded randomized controlled trial. Two primary intervention groups (A and B) will receive manual therapy (MT) in the same out-patient clinic. In addition, group A will receive a remote, novel, computer-based cervical kinaesthetic exercise program starting at visit two, whereby quality and quantity of exercise performance, as well as compliance (frequency and duration), will be registered into the physical therapy clinic's system for evaluation. Group B will receive neck exercises (not computer-based) provided by the corresponding physical therapist. Group A will continue remote exercise therapy until 6 months post baseline measurements regardless of whether they are still being treated in-clinic or discharged.

Hypothesis 1.a.: Internet-based neck-specific CKE combined with in-clinic manual therapy and exercises will be superior to manual therapy and exercises alone at a physiotherapy clinic (i.e., treatment A is superior to treatment B) for self-reported and measured (movement performance) outcome measures.

Hypothesis 1.b.: Improvements in self-reported outcomes will positively correlate with outcomes of movement performance testing, as will the pre- to post-intervention changes from baseline to follow-up assessments.

The groups will be compared to a "treatment as usual" group (C). Objective measures include measurements for motor control, proprioception, and cervical range of motion. Neck disability and pain intensity, general health, self-perceived handicap, and physical, emotional and functional difficulties due to dizziness will be measured using questionnaires. Short-term effects will be measured at 10-12 weeks and long-term effects at 6- and 12-months post baseline measurements.

Hypothesis 2.a.: Participants of groups A and B will improve significantly more than those in group C for subjective and objective outcome measures.

Conditions

  • Whiplash Injury of Cervical Spine

Interventions

OTHER

Manual therapy

Individualized treatment of manual therapy provided by MT PTs, graduates from Curtin University of Technology, Perth, Australia (2008)

DEVICE

Telehealth exercises

A novel, remote computer based cervical joint positioning exercise and cervical kinaesthetic exercise (CKE) program. A technical consultant monitors the data from the remote exercises and inform the PTs if someone has not done their exercises in over 2 weeks during the study period so subjects can be encouraged with a friendly reminder.

OTHER

Non-computer based exercises

Home-exercises in the need of each subject (pragmatic approach) taught by MT PTs, graduates from Curtin University of Technology, Perth, Australia (2008)

Sponsors & Collaborators

  • Empowered Health

    collaborator UNKNOWN
  • Reykjavik University

    collaborator OTHER
  • Landspitali University Hospital

    collaborator OTHER
  • University of Iceland

    lead OTHER

Principal Investigators

  • Kristín Briem, PhD · University of Iceland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
63 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-27
Primary Completion
2023-06-30
Completion
2024-04-30

Countries

  • Iceland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05319808 on ClinicalTrials.gov