Clinical trial NCT05581537: Effect of Adding Systematic Desensitization to Goal Directed Paradigm on Risk of Falling in Patients With Stroke
Official title: Effect of Adding Systematic Desensitization to Goal Directed Paradigm on Risk of Falling in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Both genders will be involved
2. Duration of the disease is more than 3 months.
3. Ischemic and hemorrhagic stroke will be included
4. Left sided hemiparesis
5. Hemiparetic patient, degree of spasticity for upper and lower limbs ranges from (grade 1+ : 2 ) according to modified Aschworth scale
6. Patient's age ranges from 45 to 60 years.
7. Patient's ability to stand independently for at least 5 minutes without the use of an assistive device.
8. Patients with sufficient cognitive abilities that enables them to understand and follow instructions (The Montreal Cognitive Assessment score \>26) (Appendix II).
9. Body mass index for patients will not be more than 30.

Exclusion Criteria:

1. Neurological diseases that affect gait other than stroke (eg: Multiple sclerosis, Peripheral neuropathy, Parkinsonism etc.).
2. 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.
3. 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.
4. Visual, auditory and speech problems.

Primary outcomes:
measure: Dynamic Gait Index
timeFrame: 1 year
measure: Berg Balance Scale
timeFrame: 1 year
measure: Falls Efficacy Scale - International (FES-I)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October 6 University
Study officials:
References: