Patient Education Program and Trunk Control Exercises in Post-stroke

NCT ID: NCT06679699

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-15
• Study Completion Date: 2024-10-16

Brief Summary

The trunk movement awareness and education of individuals with post-stroke hemiparesis is not emphasized adequately in clinical practice. Therefore, this current study was made to hypothesize whether a patient education program about dynamic trunk control exercises during stroke rehabilitation may influence trunk control. 40 individuals with post-stroke hemiparesis were recruited and randomly allocated to the experimental and control group. Both the groups received 1 hour of exercises focusing more on dynamic trunk control exercises with patient education chart (experimental group) and without the patient education chart (control group) for 4 weeks.

Detailed Description

The prevalence of stroke in adults increased by 14.6% in 2022 compared to data collected in 2013. Poor balance, postural asymmetry, abnormal gait, and fall-related complications due to reduced trunk control can limit social interactions. Trunk control is an important predictor of functional independence for stroke-affected individuals recovering from functional impairments. Studies have found that individuals with post-stroke hemiparesis have mild-to-severe trunk dysfunction even 6 months post-stroke occurrence. Evidence also indicates that the muscular strength of the trunk is significantly reduced in acute and chronic stages, which leads to poor functional performance. As trunk function significantly contributes to functional recovery, the importance of trunk training needs to be emphasized, and education should be provided to stroke patients for faster functional mobility.

Patient education programs guide patients, caregivers, and family members to understand and promote the patient's participation in continuing care and treatment decisions. This method assists patients in incorporating information, expertise, beliefs, and behaviors related to their health promotion and faster functional recovery from physical and psychological impairments. Patient education provides adequate and appropriate scientific knowledge for patients to improve their awareness of illness conditions and health-promoting practices. Studies also suggest that the patient education process increases patient's involvement in rehabilitation practices.

Although trunk control exercises are performed during routine rehabilitation programs, knowledge and education about trunk training exercises are not specifically emphasized in stroke rehabilitation protocols. Stroke patients need to be educated not only about upper and lower functional training but also should understand trunk control training during their rehabilitation process to acquire skills.

In this proposed study, a patient education program highlighting the significance of trunk control, its role in functional improvement, and patient-centered self-care might provide better functional mobility compared to a standalone trunk control exercises program. Through this program, patients can concentrate not only on limb training but also emphasize trunk-related functional tasks to improve overall body function. Therefore, our current study hypothesized that a patient education program about the trunk training program during the rehabilitation process may improve balance and functional mobility better than a standalone trunk control exercises program in patients with post-stroke hemiparesis.

Conditions

Strokes Thrombotic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Trunk control exercises with Patient education program

This group have received Trunk control exercises along with patient education program.

Group Type: EXPERIMENTAL

Trunk control exercises combined with patient education program

Intervention Type: DEVICE

Patients in this group received about 45-60 minutes of trunk control exercises in lying and sitting, 5 days a week for 4 consecutive weeks. Each exercise was performed with 10-20 repetitions per session depending on the patient's ability. Trunk exercises or other activities targeting the trunk while sitting and lying, to minimize the influence of lower extremity function performed either on a stable or unstable surfaces. In addition, the experimental group provided a patient education program which focuses on the importance of trunk control and benefits of trunk control exercises during the rehabilitation process. Further, caregivers and family members were also explained about the patient education program and adherence with treatment protocol during and after the interventions.

Trunk control exercises

This group have received standalone trunk control exercises.

Group Type: ACTIVE_COMPARATOR

Trunk control exercises

Intervention Type: DEVICE

Patients in this group received about 45-60 minutes of trunk control exercises in lying and sitting, 5 days a week for 4 consecutive weeks. Each exercise was performed with 10-20 repetitions per session depending on the patient's ability. Trunk exercises or other activities targeting the trunk while sitting and lying, to minimize the influence of lower extremity function performed either on a stable or unstable surfaces.

Interventions

Trunk control exercises combined with patient education program

Patients in this group received about 45-60 minutes of trunk control exercises in lying and sitting, 5 days a week for 4 consecutive weeks. Each exercise was performed with 10-20 repetitions per session depending on the patient's ability. Trunk exercises or other activities targeting the trunk while sitting and lying, to minimize the influence of lower extremity function performed either on a stable or unstable surfaces. In addition, the experimental group provided a patient education program which focuses on the importance of trunk control and benefits of trunk control exercises during the rehabilitation process. Further, caregivers and family members were also explained about the patient education program and adherence with treatment protocol during and after the interventions.

Intervention Type: DEVICE

Trunk control exercises

Patients in this group received about 45-60 minutes of trunk control exercises in lying and sitting, 5 days a week for 4 consecutive weeks. Each exercise was performed with 10-20 repetitions per session depending on the patient's ability. Trunk exercises or other activities targeting the trunk while sitting and lying, to minimize the influence of lower extremity function performed either on a stable or unstable surfaces.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Diagnosed with ischemic stroke
• Grade 1 - 2 Spasticity
• Hemiparesis

Exclusion Criteria

• Moderate to severe cognitive deficits,
• Alzheimer's disease,
• Language difficulties,
• Unstable blood pressure
• Uncontrolled epilepsy,
• Dislocations/fractures

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gulf Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ramprasad Muthukrishnan, PDF

Role: STUDY_CHAIR

Gulf Medical University

Locations

Gulf Medical University

Ajman, , United Arab Emirates

Countries

United Arab Emirates

Other Identifiers

IRB-COHS-STD-09-DEC-2020

Identifier Type: -

Identifier Source: org_study_id