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

November 5, 2020 updated by: University of Malaya
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

General study objective: to measure the effect of cognitive rehabilitation program for attention deficit applied in mild traumatic brain injury patients.

Specific objectives:

  1. To measure the effect of a 12-week cognitive rehabilitation therapy for attention deficits in mild traumatic brain injury patients using neuropsychological and functional assessments.
  2. To examine the correlation between neurocognitive deficits and structural brain changes at baseline and at six months post injury.

Study type and location: An interventional study conducted in University Malaya Medical Centre (UMMC), Malaysia.

Participants: Patients diagnosed with mild traumatic brain injury at Accident & Emergency Department in UMMC.

Outcome measures:

  1. Neuropsychological Assessment Battery-Screening test
  2. Diffusion Tensor Imaging parameters
  3. Goal Attainment Scaling

Ethics approval: approved MREC ID NO: 2016928-4293

Consent: informed written consent will be obtained from all participants of research.

Estimated sample size:

Based on medium effect size Cohen's d = 0.35 Investigators used G*Power Version 3.1.9.2 for sample size calculation. Sample size calculated: 60 Estimating drop out rate of 40%=24. Therefore sample size target n= 84 mTBI patients.

Study design:

A two arm randomised controlled trial:

  1. Mild traumatic brain injury control group, and
  2. Mild traumatic brain injury intervention group.

The study protocol is divided into 3 segments:

  1. Neurocognitive evaluation protocol:

    Investigators will perform Neuropsychological Assessment Battery-Screening test on both groups at three months and at six months following brain injury.

  2. Imaging protocol:

    Investigators perform Diffusion Tensor Imaging for both groups at three months and at six months following brain injury.

  3. Cognitive rehabilitation therapy protocol:

The focus is on attention deficits. Each study arm will receive different treatment approaches.

Mild traumatic brain injury control group will receive a patient-centred cognitive therapy. This is an application of existing cognitive rehabilitation treatment available at UMMC, which include therapy session on symptoms management and coping strategies. This is performed and monitored by a cognitive therapy trained Occupational Therapist. Clinical and treatment review are provided as part of routine outpatient rehabilitation clinic review.

Mild traumatic brain injury intervention group will receive individualised structured cognitive rehabilitation therapy that consist of:

  1. Direct attention training:

    A deficit-oriented evidence-based treatment approach. The therapy for attention is computer-based and is divided into focused attention, selective attention, divided attention and sustained attention. Each treatment session is conducted by a trained Occupational Therapist in cognitive therapy and a rehabilitation medicine physician.

  2. Strategic approach (metacognitive):

This involves generalisation of tasks to everyday functional skills. This approach is applied after each direct attention training session. This approach include review of individualised goals, review of cognitive related problem(s) encountered in participants daily activities since injury and problem-solving training. This is also performed by similar trained Occupational Therapist and reviewed by a rehabilitation medicine physician.

Randomisation sampling: Investigators apply simple randomisation in selection of mild traumatic brain injury control and intervention group participants.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Wilayah Persekutuan
      • Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
        • University Malaya Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mild traumatic brain injury as a result of motor vehicle accidents only.
  • No previous history of head trauma.
  • Education level of a minimum of 9 years (required for neuropsychological test).
  • Normal Computed Tomography (CT) brain scan finding.
  • Able to comply with cognitive rehabilitation therapy.
  • No pre-existing chronic illness that can cause neurological complications, neurological diseases or psychiatric condition.
  • Not on any regular medication that may alter or effect cognitive and psychological status.

Exclusion Criteria:

  • Normal neuropsychological assessment test result at 3 months post injury (planned test time) for both study groups.
  • Clinical evidence of alcohol influence at time of injury.
  • Non Malaysian citizens
  • Major polytrauma including long bone fractures, intra-abdominal injuries and chest injuries that require surgical and/or metal insertion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individualised structured cognitive rehabilitation therapy
Participants of interventional arm will receive individualised structured cognitive rehabilitation therapy at the proposed health centre (University Malaya Medical Centre, Malaysia).
Other: Structured cognitive rehabilitation therapy
A computer-based cognitive rehabilitation therapy Therapy frequency is one hour session per week for three months.
Other Names:
  • cognitive therapy
  • CogniPlus
Active Comparator: Patient-centred cognitive therapy
Participants of conventional arm will receive an existing cognitive rehabilitation treatment available at the proposed health centre (University Malaya Medical Centre, Malaysia).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Neuropsychological Assessment Battery- Screening score
Time Frame: Perform at 3 months (pre-intervention) and 6 months (completed intervention) following mild traumatic brain injury
Measure the change in score of Attention domain screening score and Total Screening Index Score at two different time points - 3 months and 6 months post brain injury.
Perform at 3 months (pre-intervention) and 6 months (completed intervention) following mild traumatic brain injury

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Diffusion Tensor Imaging parameters
Time Frame: Perform at 3 months (pre-intervention) and 6 months (completed intervention) following mild traumatic brain injury
Measure the change in mean values of white matter tract parameters at two different time points - 3 months and 6 months post brain injury.
Perform at 3 months (pre-intervention) and 6 months (completed intervention) following mild traumatic brain injury
Change in Goal Attainment Scaling score
Time Frame: Perform at 3 months (baseline) and 6 months (complete intervention) following mild traumatic brain injury
Measure the change in Goal Attainment Scaling calculation score at two different time points - 3 months and 6 months post brain injury.
Perform at 3 months (baseline) and 6 months (complete intervention) following mild traumatic brain injury

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Principal Investigator: Norhamizan Hamzah, MBChB,MRehabMed, Rehabilitation Medicine Specialist, University of Malaya
  • Study Chair: Mazlina Mazlan, MBBS,MRehabMed, Consultant Rehabilitation Medicine & Associate Professor, University of Malaya
  • Study Chair: Vairavan Narayanan, MBBS,MSURG,FRCS, Consultant Neurosurgeon & Associate Professor, University of Malaya
  • Study Chair: Norlisah Ramli, MBBS,FRCR, Consultant Neuroradiologist & Professor, University of Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2017

Primary Completion (Actual)

April 30, 2019

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

July 18, 2017

First Submitted That Met QC Criteria

July 30, 2017

First Posted (Actual)

August 2, 2017

Study Record Updates

Last Update Posted (Actual)

November 6, 2020

Last Update Submitted That Met QC Criteria

November 5, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PO037-2015A

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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