The Effect of Cognitive Rehabilitation Therapy in Improving Cognitive Function of Attention Following Mild Traumatic Brain Injury

NCT03237676 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-11-06

No results posted yet for this study

Summary

This research is a randomised controlled study. The study hypothesis is cognitive rehabilitation for attention deficits following mild traumatic brain injury will improve patient's cognitive outcome, measured by neuropsychological and neuroimaging parameters. Participant recruitment is from University Malaya Medical Centre, Malaysia. All mild traumatic brain injury participants have to fulfil the study inclusion criteria and written consented for therapy. Control group receives existing patient-centred cognitive treatment whereas intervention group receives individualised structured cognitive rehabilitation therapy. The intervention begins at three months post injury and ends at six months post injury. Study outcome measurements are applied at pre and post treatment. This study was ethically approved by Medical Research Ethics Committee University Malaya Medical Centre (MREC ID NO: 2016928-4293).

Conditions

Interventions

OTHER

Structured cognitive rehabilitation therapy

A computer-based cognitive rehabilitation therapy Therapy frequency is one hour session per week for three months.

OTHER

Patient-centred cognitive therapy

Application of existing cognitive therapy at University Malaya Medical Centre, Malaysia. It is a patient-centred therapy approach over a period of three months, which include therapy session on symptoms management and coping strategies. Clinical and treatment review are provided as part of routine outpatient rehabilitation clinic review.

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Norhamizan Hamzah, MBChB,MRehabMed · Rehabilitation Medicine Specialist, University of Malaya

  • Mazlina Mazlan, MBBS,MRehabMed · Consultant Rehabilitation Medicine & Associate Professor, University of Malaya

  • Vairavan Narayanan, MBBS,MSURG,FRCS · Consultant Neurosurgeon & Associate Professor, University of Malaya

  • Norlisah Ramli, MBBS,FRCR · Consultant Neuroradiologist & Professor, University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-04-30
Completion
2019-12-31

Countries

  • Malaysia

Study Locations

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Entities

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 NCT03237676 on ClinicalTrials.gov