StrokeNCT05581537
Effect of Adding Systematic Desensitization to Goal Directed Paradigm on Risk of Falling in Patients With Stroke
A study testing Systematic Desensitization in people with Stroke, run by October 6 University at 1 site in Egypt.
Trial summary
Stroke is the leading cause of disability in the elderly . The most common manifestations of stroke are deficits in motor control that involve abnormal synergistic organization of movements, muscle weakness, sensory deficits, and loss of range of motion. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Systematic Desensitization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders will be involved
- Duration of the disease is more than 3 months.
- Ischemic and hemorrhagic stroke will be included
- Left sided hemiparesis
- Hemiparetic patient, degree of spasticity for upper and lower limbs ranges from (grade 1+ : 2 ) according to modified Aschworth scale
- Patient's age ranges from 45 to 60 years.
Show all 9Show fewer
- Patient's ability to stand independently for at least 5 minutes without the use of an assistive device.
- Patients with sufficient cognitive abilities that enables them to understand and follow instructions (The Montreal Cognitive Assessment score >26) (Appendix II).
- Body mass index for patients will not be more than 30.
Who cannot join
- Neurological diseases that affect gait other than stroke (eg: Multiple sclerosis, Peripheral neuropathy, Parkinsonism etc.).
- Musculoskeletal disorders such as severe arthritis, knee surgery, total hip joint replacement, lower limb fractures less than 6 months or contractures of fixed deformity, leg length discrepancy.
- Cardiovascular problems (unstable angina, recent myocardial infarction within the last three months, congestive heart failure, significant heart valve dysfunction, or unstable hypertension) or pulmonary disorders.
- Visual, auditory and speech problems.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
October 6 University
Giza
Ahmed Alshimy, PHD, 0201115116030, ahmed.magdy.pt@o6u.edu.eg
About this study
Stroke is the leading cause of disability in the elderly . The most common manifestations of stroke are deficits in motor control that involve abnormal synergistic organization of movements, muscle weakness, sensory deficits, and loss of range of motion. Poor posture, which is one of its main symptoms, affects falls or injured falls.
Fear of falling is a psychological condition associated with balance disorders and fall risks after a stroke.
Read the detailed description
Fear of falling can result in avoidance behavior, leading to inactivity and social isolation, and further exacerbate disability in stroke populations Systematic desensitization , one of cognitive behavior therapy (CBT), is a psychotherapeutic intervention designed to modify unrealistic beliefs that can contribute to negative emotions and behavior. Fear of falling could result from accurate perceptions of impaired balance ability and unrealistic beliefs about one's risk of falling.
Systematic desensitization may alter these self-defeating beliefs and thus reduce fear-avoidance behavior and the associated adverse consequences, such as limited social participation and is effective in reducing the fear of falling among older individuals Goal-directed training is an activity-based approach to therapy. Meaningful, client-selected goals are used to provide opportunities for problem solving and to indirectly drive the movements required to successfully meet the task demands. This is in contrast to interventions that focus on changing body functions. The approach is based on the dynamic systems motor control theory and occupation-based therapy models, which suggest that movement patterns emerge from the interaction between the person's abilities, environment and the goal. Four components provide the basis for goal-directed training: (1) selection of a meaningful goal; (2) analysis of baseline performance; (3) intervention/ practice regime; and (4) evaluation of outcome.
- Conditions
- Stroke
- Being tested
- Systematic Desensitization
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic DesensitizationOther
Also called Goal directed paradigm
Systematic desensitization: 2 techniques
- Jacobson's technique (progressive muscle relaxation): It involves tensing and releasing muscles that progress through the body throughout focusing on mental relaxation throughout releasing muscle tension
- Guided imagery (vividly imagining):
It includes 2 types of imagery training/mental practice (MP) which includes visual imagery is based on the sensory (visual) perception of the imagined movement and Kinesthetic imagery is based on sensory-motor information (proprioceptive). MP will be conducted in a quiet room, where each patient will be given detailed instructions to perform both visual and kinesthetic practice
| Study group | Role | What they receive |
|---|---|---|
| Study group (GA) | Experimental | receive systematic desensitization in addition to goal directed paradigm for eight weeks, Three sessions per week (1hour and half) Receives: Other: Systematic Desensitization |
| Control group (GB) | Experimental | receive goal directed paradigm for eight weeks, Three sessions per week (45 minutes) Receives: Other: Systematic Desensitization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Gait Index
the DGI tests the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. It is a useful test in individuals with vestibular and balance problems and those at risk of falls.
It includes eight items, walking on level surfaces, changing speeds, head turns in horizontal and vertical directions, walking and turning 180 degrees to stop, stepping over and around obstacles, and stair ascent and descent.
Each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment.
The best possible score on the DGI is a 24
Measured: 1 year
Berg Balance Scale
is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
Measured: 1 year
Falls Efficacy Scale - International (FES-I)
It is a 16 item questionnaire, useful to the researchers and clinicians interested in fear of falling, with a score ranging from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start1 Jul 2022
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Gaber, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581537
- Sponsor's protocol ID
- P.T.REC/012/003940
- Status last verified
- Nov 2022
- First submitted
- 17 Jul 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Systematic Desensitization to Goal Directed Paradigm on Risk of Falling in Patients With Stroke
- ClinicalTrials.gov ID
- NCT05581537
- Acronym / sponsor ID
- P.T.REC/012/003940
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Stroke is the leading cause of disability in the elderly . The most common manifestations of stroke are deficits in motor control that involve abnormal synergistic organization of movements, muscle weakness, sensory deficits, and loss of range of motion. Poor posture, which is one of its main symptoms, affects falls or injured falls.
Fear of falling is a psychological condition associated with balance disorders and fall risks after a stroke.
Detailed description
Fear of falling can result in avoidance behavior, leading to inactivity and social isolation, and further exacerbate disability in stroke populations Systematic desensitization , one of cognitive behavior therapy (CBT), is a psychotherapeutic intervention designed to modify unrealistic beliefs that can contribute to negative emotions and behavior. Fear of falling could result from accurate perceptions of impaired balance ability and unrealistic beliefs about one's risk of falling.
Systematic desensitization may alter these self-defeating beliefs and thus reduce fear-avoidance behavior and the associated adverse consequences, such as limited social participation and is effective in reducing the fear of falling among older individuals Goal-directed training is an activity-based approach to therapy. Meaningful, client-selected goals are used to provide opportunities for problem solving and to indirectly drive the movements required to successfully meet the task demands. This is in contrast to interventions that focus on changing body functions. The approach is based on the dynamic systems motor control theory and occupation-based therapy models, which suggest that movement patterns emerge from the interaction between the person's abilities, environment and the goal. Four components provide the basis for goal-directed training: (1) selection of a meaningful goal; (2) analysis of baseline performance; (3) intervention/ practice regime; and (4) evaluation of outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group (GA) | Experimental | Other: Systematic Desensitizationreceive systematic desensitization in addition to goal directed paradigm for eight weeks, Three sessions per week (1hour and half) |
| Control group (GB) | Experimental | Other: Systematic Desensitizationreceive goal directed paradigm for eight weeks, Three sessions per week (45 minutes) |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Both genders will be involved
- Duration of the disease is more than 3 months.
- Ischemic and hemorrhagic stroke will be included
- Left sided hemiparesis
- Hemiparetic patient, degree of spasticity for upper and lower limbs ranges from (grade 1+ : 2 ) according to modified Aschworth scale
Key exclusion criteria (4 listed)
- Neurological diseases that affect gait other than stroke (eg: Multiple sclerosis, Peripheral neuropathy, Parkinsonism etc.).
- Musculoskeletal disorders such as severe arthritis, knee surgery, total hip joint replacement, lower limb fractures less than 6 months or contractures of fixed deformity, leg length discrepancy.
- Cardiovascular problems (unstable angina, recent myocardial infarction within the last three months, congestive heart failure, significant heart valve dysfunction, or unstable hypertension) or pulmonary disorders.
- Visual, auditory and speech problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systematic DesensitizationAlso: Goal directed paradigmSystematic desensitization: 2 techniques 1. Jacobson's technique (progressive muscle relaxation): It involves tensing and releasing muscles that progress through the body throughout focusing on mental relaxation throughout releasing muscle tension 2. Guided imagery (vividly imagining): It includes 2 types of imagery training/mental practice (MP) which includes visual imagery is based on the sensory (visual) perception of the imagined movement and Kinesthetic imagery is based on sensory-motor information (proprioceptive). MP will be conducted in a quiet room, where each patient will be given detailed instructions to perform both visual and kinesthetic practice | Other | Control group (GB), Study group (GA) |
Primary outcome
Dynamic Gait Index
Time frame: 1 year
the DGI tests the ability of the participant to maintain walking balance while responding to different task demands, through various dynamic conditions. It is a useful test in individuals with vestibular and balance problems and those at risk of falls. It includes eight items, walking on level surfaces, changing speeds, head turns in horizontal and vertical directions, walking and turning 180 degrees to stop, stepping over and around obstacles, and stair ascent and descent. Each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best possible score on the DGI is a 24
Berg Balance Scale
Time frame: 1 year
is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.
Falls Efficacy Scale - International (FES-I)
Time frame: 1 year
It is a 16 item questionnaire, useful to the researchers and clinicians interested in fear of falling, with a score ranging from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic Desensitization in people with Stroke, run by October 6 University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Alshimy, PHD (0201115116030, ahmed.magdy.pt@o6u.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Gait Index (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.