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

NCT ID: NCT05581537

Last Updated: 2022-11-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2024-07-01

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Study group (GA)

receive systematic desensitization in addition to goal directed paradigm for eight weeks, Three sessions per week (1hour and half)

Group Type: EXPERIMENTAL

Systematic Desensitization

Intervention Type: OTHER

Systematic 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

Control group (GB)

receive goal directed paradigm for eight weeks, Three sessions per week (45 minutes)

Group Type: EXPERIMENTAL

Systematic Desensitization

Intervention Type: OTHER

Systematic 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

Interventions

Systematic Desensitization

Systematic 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

Intervention Type: OTHER

Other Intervention Names

Goal directed paradigm

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

October 6 University

OTHER

Sponsor Role: lead

Responsible Party

Heba Gaber

Assistant Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

October 6 University

Giza, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed Alshimy, PHD

Role: CONTACT

ahmed.magdy.pt@o6u.edu.eg

0201115116030

Heba Gaber, Master

Role: CONTACT

hebamohamed.pt@o6u.edu.eg

0201028222497

Facility Contacts

Ahmed Alshimy, PHD

Role: primary

ahmed.magdy.pt@o6u.edu.eg

0201115116030

Other Identifiers

P.T.REC/012/003940

Identifier Type: -

Identifier Source: org_study_id