Rehabilitation of Memory in Neurological Disabilities - Pilot study

ISRCTN	ISRCTN92582254
DOI	https://doi.org/10.1186/ISRCTN92582254
Protocol serial number	N0192147133
Sponsor	Department of Health
Funders	Queen's Medical Centre University Hospital NHS Trust (UK) NHS R&D Support Funding, Added July 2008:, Stroke Association (UK) (AHP Research Bursary), Remedi (UK)

Submission date: 30/09/2005
Registration date: 30/09/2005
Last edited: 21/02/2018

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof N Lincoln
Scientific

University of Nottingham
University Hospital
Institute of work, Health and Organisations
8 William Lee buildings, Science and Technology Park
University Boulevard
Nottingham
NG7 2RQ
United Kingdom

Phone	+44 (0)115 87523846
Email	nadina.lincoln@nottingham.ac.uk

Study information

Primary study design	Interventional
Study design	Single blind randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A comparison of the effectiveness of two types of neuropsychological rehabilitation for memory deficits following brain damage: A single blind randomised controlled trial
Study acronym	ReMIND - Pilot study
Study objectives	The aim of this study is to compare the effectiveness of two types of cognitive rehabilitation techniques (ie restitution and compensation) in reducing memory deficits following brain damage.
Ethics approval(s)	Ethical approval obtained from Central Office for Research Ethics Committees, Nottingham Research Ethics Committee 1 (12 May 2004)
Health condition(s) or problem(s) studied	Stroke, Traumatic Brain Injury (TBI), Multiple Sclerosis (MS) / memory deficits
Intervention	1. Restitution group 2. Compensation group 3. Attention placebo group
Intervention type	Other
Primary outcome measure(s)	Prior to July 2008: To assess memory functions, disability, psychological adjustment. Modified July 2008: To assess everyday memory functions, based on the Everyday Memory Questionnaire.
Key secondary outcome measure(s)	Added July 2008: Objective measures of memory (RBMTE, Doors & People, Memory Aids Questionnaire), mood (GHQ12, Wimbledon Self Report Scale), psychological adjustment (Mental Adjustment to Brain Damage), and extended activities of daily living (Nottingham EADL).
Completion date	31/01/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex
Target sample size at registration	180
Key inclusion criteria	Prior to July 2008: Participants having sustained a brain damage, verified by hospital or GP records, should have a memory deficit, defined as overall profile score of 1 (poor memory) or 0 (impaired) on the Rivermead Behavioural memory Test (RBMT), over 18 years of age, living in or around Nottingham (within 50 miles radius), having at least one identified individual who will supervise homework assignments, they give informed consent, they are not blind or deaf, should speak English, should have been diagnosed at least one month prior to recruitment to the study, should be more than one month post injury and or diagnosis, no previous diagnosis of brain damage or other severe disability. Modified July 2008: Participants with a stroke, TBI, or MS, verified by hospital or GP records, should have a memory deficit, defined as overall profile score of 2 (average memory) to 0 (impaired) on the Rivermead Behavioural memory Test-extended version (RBMTE), over 18 years of age, living in or around Nottingham or Derby (within 50 miles radius), having at least one identified individual who will supervise homework assignments, they give informed consent, should speak English, and should be more than one month post injury and or diagnosis.
Key exclusion criteria	Added July 2008: Those who are blind or deaf, have previous diagnosis of brain damage or dementia, have severe activity limitations which would restrict them from taking part in assessments or intervention, current psychiatric/mental health problems, and language problems (defined as a score of less than 15 on the Sheffield Screening Test for Acquired Language Disorders).
Date of first enrolment	24/05/2004
Date of final enrolment	31/01/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Nottingham

Nottingham
NG7 2RQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2012		Yes	No
Results article	results	19/09/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

21/02/2018: Publication reference added.