Effect of Adding Systematic Desensitization to Goal Directed Paradigm on Risk of Falling in Patients With Stroke
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Jul 2022
Typical duration for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2022
CompletedFirst Submitted
Initial submission to the registry
July 17, 2022
CompletedFirst Posted
Study publicly available on registry
October 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedNovember 22, 2022
November 1, 2022
1.1 years
July 17, 2022
November 21, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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
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.
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)
1 year
Study Arms (2)
Study group (GA)
EXPERIMENTALreceive systematic desensitization in addition to goal directed paradigm for eight weeks, Three sessions per week (1hour and half)
Control group (GB)
EXPERIMENTALreceive goal directed paradigm for eight weeks, Three sessions per week (45 minutes)
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
October 6 University
Giza, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Lecturer
Study Record Dates
First Submitted
July 17, 2022
First Posted
October 14, 2022
Study Start
July 1, 2022
Primary Completion
August 1, 2023
Study Completion
July 1, 2024
Last Updated
November 22, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share