Effect of Adding Systematic Desensitization to Goal Directed Paradigm on Risk of Falling in Patients With Stroke

Not Applicable

Recruiting

• Conditions: Stroke
• Interventions: Other: Systematic Desensitization

• Registration Number: NCT05581537
• Lead Sponsor: October 6 University

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.

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-07-17
• Study First Submitted QC: 2022-10-13
• Study First Posted: 2022-10-14
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-21
• Last Update Posted: 2022-11-22
• Primary Completion: 2023-08-01
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Control group (GB)	Systematic Desensitization	receive goal directed paradigm for eight weeks, Three sessions per week (45 minutes)
Study group (GA)	Systematic Desensitization	receive systematic desensitization in addition to goal directed paradigm for eight weeks, Three sessions per week (1hour and half)

Primary Outcome Measures

Name	Time	Method
Berg Balance Scale	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.
Dynamic Gait Index	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
Falls Efficacy Scale - International (FES-I)	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)

Trial Locations

Locations (1)

October 6 University; 🇪🇬 Giza, Egypt