Comparison of TTE and LTTBT on Trunk Control, Balance and ADL's in Stroke Patients

NCT ID: NCT07248618

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-17
• Study Completion Date: 2025-12-30

Brief Summary

To compare the effects of trunk training exercises and lateral truncal tilt balance training on trunk control, balance and activities of daily living in stroke patients.The primary outcome measures used to evaluate the efficacy of each training approach will include the Timed Up and Go (TUG) test, assessing mobility and fall risk; the Berg Balance Scale (BBS), which measures functional balance; and the Trunk Impairment Scale (TIS), evaluating trunk control and coordination.

Detailed Description

Stroke is a significant cause of disability globally, affecting millions each year. Stroke patients frequently experience impairments in trunk control and balance, critical factors for independence in activities of daily living (ADLs). Two promising therapeutic approaches include Trunk Training Exercises (TTE) focusing on core stability and Lateral Truncal Tilt Balance Training (LTT), which targets balance and postural alignment through controlled lateral movements. This study aims to compare the effectiveness of these two interventions in improving trunk control, balance, and ADLs in stroke patients, potentially leading to optimized rehabilitation practices. A randomized clinical trial will be conducted at Jinnah Hospital, Lahore. Participants aged 40 75, diagnosed with sub-acute stroke, will be randomly assigned to one of two groups: Group A, which will undergo trunk training exercises (TTE), and Group B, which will receive lateral truncal tilt balance training (LTT). Each intervention will last for eight weeks and thrice a week, with a session of 45 minutes including warm-up exercises, main exercises and cool down period during which participants will engage in their respective training regimens. To assess the impact of these interventions, baseline measurements will be taken prior to the intervention and compared to post-intervention results. The primary outcome measures used to evaluate the efficacy of each training approach will include the Timed Up and Go (TUG) test, assessing mobility and fall risk; the Berg Balance Scale (BBS), which measures functional balance; and the Trunk Impairment Scale (TIS), evaluating trunk control and coordination. Data analysis will be conducted using SPSS software (version 25). To determine the distribution of data, the Shapiro-Wilk Test will be performed. If the data is not normally distributed, the Wilcoxon Signed Rank Test will be used to analyze within-group differences, while the Mann-Whitney U Test will assess differences between groups at each interval. For normally distributed data, Paired Sample T-tests will compare pre- and post-intervention scores within each group, and Independent Sample T-tests will evaluate changes between groups.

Inclusion criteria is:

Patients with ischemic stroke Both male and females Age 40-75 years Patients diagnosed with sub-acute stroke after six months to 1.5 years of diagnosis Patients able to walk 10 meters independently Score less than 21 on trunk impairment scale Patients with score 24 or more on MMSE

Exclusion criteria is:

Patients with score more than 2 on modified Ashworth scale will be excluded Chronic patients will not be included in the study.

Conditions

Stroke

Study Design

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

Study Groups

Trunk Training Exercises

Core Stabilization Exercises, dynamic trunk exercises, bridging exercises

Group Type: ACTIVE_COMPARATOR

Trunk Training Exercises

Intervention Type: OTHER

Group A will undergo a structured trunk training exercise program focused on strengthening the core muscles involved in trunk control. This program will include both dynamic and static exercises targeting trunk flexion, extension, and rotation, which are critical for improving postural stability and overall trunk coordination.

Frequency: Sessions will be conducted three times per week for the duration of 8 weeks.

Session Duration: Each session will last approximately 45 minutes, including a warm-up, main exercises, and a cool-down period.

Lateral Truncal Tilt Balance Training

Seated lateral tilts, Standing Lateral Weight Shifts, balance board tilts, Stability Ball Exercises, lateral Reaches on Unstable Surface

Group Type: EXPERIMENTAL

Lateral Truncal Tilt Balance Training

Intervention Type: OTHER

Group B will follow a lateral truncal tilt balance training program focusing on balance improvement through lateral stability exercises. This training emphasizes body tilts and weight shifts to encourage trunk control and postural alignment, particularly targeting the common lateral asymmetries observed in stroke patients.

Frequency: Sessions will be conducted three times per week for 8 weeks. Session Duration: Each session will last approximately 45 minutes, including warm-up, main exercises, and a cool-down period.

Interventions

Trunk Training Exercises

Group A will undergo a structured trunk training exercise program focused on strengthening the core muscles involved in trunk control. This program will include both dynamic and static exercises targeting trunk flexion, extension, and rotation, which are critical for improving postural stability and overall trunk coordination.

Frequency: Sessions will be conducted three times per week for the duration of 8 weeks.

Session Duration: Each session will last approximately 45 minutes, including a warm-up, main exercises, and a cool-down period.

Intervention Type: OTHER

Lateral Truncal Tilt Balance Training

Group B will follow a lateral truncal tilt balance training program focusing on balance improvement through lateral stability exercises. This training emphasizes body tilts and weight shifts to encourage trunk control and postural alignment, particularly targeting the common lateral asymmetries observed in stroke patients.

Frequency: Sessions will be conducted three times per week for 8 weeks. Session Duration: Each session will last approximately 45 minutes, including warm-up, main exercises, and a cool-down period.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with ischemic stroke
• Both male and females
• Age 40-75 years
• Patients diagnosed with sub-acute stroke after six months to 1.5 years of diagnosis
• Patients able to walk 10 meters independently
• Score less than 21 on trunk impairment scale
• Patients with score 24 or more on MMSE

Exclusion Criteria

• Patients with score more than 2 on modified Ashworth scale will be excluded
• Chronic patients will not be included in the study.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aruba Saeed, Phd*

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Jinnah hospital

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Hafsa Fayyaz, MS-NMPT

Role: CONTACT

hafsa.fayyaz78690@gamil.com

03229425544

Facility Contacts

Hafsa Fayyaz, MS-NMPT

Role: primary

hafsa.fayyaz78690@gmail.com

0322-9425544

Fatima Tariq, MS-NMPT

Role: backup

fatima.tariq@riphah.edu.pk

O334-4255033

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Other Identifiers

REC/02102

Identifier Type: -

Identifier Source: org_study_id