Plain English Summary
Background and study aims
The current treatment of stroke focuses on early diagnosis and early use of medication that improves the disease. However, a major proportion of patients has remaining disability and still needs rehabilitation. Depression after ischemic stroke is one of the major problems complicating the rehabilitation. A major challenge is therefore to help patients maintain self-management strategies introduced in the rehabilitation period, and thereby enhance a longer lasting effect of rehabilitation.
Goal planning or goal setting is considered an important part of stimulation techniques in rehabilitation. Several studies show that goal planning can influence patients' adherence to treatment regimes and improve immediate patient performance, but evidence regarding how it may improve results after rehabilitation programs is inconsistent. Rehabilitation goals often address motor recovery not mental and behavioral elements. A new and potentially more effective rehabilitation program has been developed. The main aim of this study is to measure the usefulness of this new rehabilitation program compared to the current traditional rehabilitation programs. The expected usefulness of the new program will be expressed in terms of goal attainment and health benefits for participating patients, and with regard to if it helps with the recovery process.
Who can participate?
Patients who are admitted to the clinic of nervous diseases with cerebral ischemic stroke.
What does the study involve?
Participants will be randomly allocated to one of two groups. While one group will receive traditional rehabilitation, the other group will also receive the new SeStDe program.
What are the possible benefits and risks of participating?
All participants will receive rehabilitation which may improve their health and physical function. There are no known risks to participants.
Where is the study run from?
The study takes place at the clinic of nervous diseases of Irkutsk State Medical University (Russia).
When is the study starting and how long is it expected to run for?
Patients will be enrolled in the study between August 2010 and August 2012. Follow-up examinations will continue until August 2013.
Who is funding the study?
Irkutsk State Medical University (Russia).
Who is the main contact?
Dr Yury Bykov
bykov1971@mail.ru
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A randomised controlled study in patients with ischemic stroke treated with antidepressant sertraline (Stimuloton) and rhythmic stimulation in Irkutsk, Russia
Acronym
SeStDe
Study hypothesis
Effectiveness rehabilitation in patients with cerebral ischemic stroke remains one of the most actual problems in neurology. A depression following an ischemic stroke is one of the major problems complicating the rehabilitation. We suggest effectiveness of treatment including traditional therapy, the antidepressant sertraline (Stimuloton), and external rhythmic stimulation in the rehabilitation of patients with post-stroke depression.
Ethics approval
Irkutsk State Medical University, 12/12/2006
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Rehabilitation after stroke
Intervention
1. 30 depressive patients were treated by standard treatment
2. 31 patients received this standard treatment with additional rhythmic stimulation - rhythmic stimulation was presented by light and sound stimulation in individual regimes with hand tapping on keyboard of PC. There are seven regimes of stimulation:
1. Individual spontaneous rhythm, prescribing frequency of stimulus in following regimes
2. Sound stimulation with contemporary hands tapping
3. Sound stimulation with delayed tapping after sound stimulus
4. Light stimulation with contemporary tapping
5. Light stimulation with delayed tapping after light stimulus
6. Light-sound stimulation with contemporary tapping
7. Light-sound stimulation with delayed tapping after light-sound stimulus
Every day stimulation will be prescribed for stroke patients. Duration of intervention: 20-21 days. All patients were assessed twice: 1 day (before treatment), 20-21 day (after beginning of prescribed treatment). Catamnesis of patients including this investigation were carried out in 6-12 months.
3. 15 of them received rhythmic stimulation and sertraline (Stimuloton), 100 mg/day
4. 60 patients had no depressive symptoms
Intervention type
Drug
Phase
Not Applicable
Drug names
Sertraline (Stimuloton)
Primary outcome measure
1. Lindmark Scale (LI)
2. The Hamilton Depression Rating Scale (HDRS)
3. The Hospital Anxiety Depression Scale
4. SF-36
Assessed on day of admittance of patients and on day 20 or 21 of treatment
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/09/2006
Overall trial end date
01/03/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients after ischemic stroke
2. No seizures
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
121
Participant exclusion criteria
1. Patients with sever cognitive impairments
2. Epileptic seizures
Recruitment start date
01/09/2006
Recruitment end date
01/03/2012
Locations
Countries of recruitment
Russian Federation
Trial participating centre
Krasnogo Vosstania, 1
Irkutsk
664003
Russian Federation
Sponsor information
Organisation
Irkutsk State Medical University (Russia)
Sponsor details
Krasnogo Vosstania
1
Irkutsk
664003
Russian Federation
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Irkutsk State Medical University (Russia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list