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

Official title

Comparison of Trunk Training Exercises and Lateral Truncal Tilt Balance Training on Trunk Control, Balance and Activities of Daily Living in Stroke Patients

Overview

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.

Interventions

• Other 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 wa
• 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,

Primary outcome measures

• Timed up and go test (TUG) [Time frame: 1-2 min]

Secondary outcome measures (1)

• Berg balance scale (BBS) [Time frame: 15 to 20 min]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Pakistan · 1 center

• Jinnah hospital — Lahore

Publications

• Tu WJ, Wang LD; Special Writing Group of China Stroke Surveillance Report. China stroke surveillance report 2021. Mil Med Res. 2023 Jul 19;10(1):33. doi: 10.1186/s40779-023-00463-x. PMID 37468952
• Murphy SJ, Werring DJ. Stroke: causes and clinical features. Medicine (Abingdon). 2020 Sep;48(9):561-566. doi: 10.1016/j.mpmed.2020.06.002. Epub 2020 Aug 6. PMID 32837228
• Lee K. The Relationship of Trunk Muscle Activation and Core Stability: A Biomechanical Analysis of Pilates-Based Stabilization Exercise. Int J Environ Res Public Health. 2021 Dec 4;18(23):12804. doi: 10.3390/ijerph182312804. PMID 34886530
• Karthikbabu S, Verheyden G. Relationship between trunk control, core muscle strength and balance confidence in community-dwelling patients with chronic stroke. Top Stroke Rehabil. 2021 Mar;28(2):88-95. doi: 10.1080/10749357.2020.1783896. Epub 2020 Jun 23. PMID 32574524
• Pellicciari L, Sodero A, Campagnini S, Guolo E, Basagni B, Castagnoli C, Hochleitner I, Paperini A, Gnetti B, Avila L, Romano E, Grippo A, Hakiki B, Carrozza MC, Mannini A, Macchi C, Cecchi F. Factors influencing trunk control recovery after intensive rehabilitation in post-stroke patients: a multicentre prospective study. Top Stroke Rehabil. 2023 Mar;30(2):109-118. doi: 10.1080/10749357.2021.2016 PMID 34994302
• Martins LG, Molle da Costa RD, Alvarez Sartor LC, Thomaz de Souza J, Winckler FC, Regina da Silva T, Modolo GP, Nunes HRC, Bazan SGZ, Martin LC, Luvizutto GJ, Bazan R. Clinical factors associated with trunk control after stroke: A prospective study. Top Stroke Rehabil. 2021 Apr;28(3):181-189. doi: 10.1080/10749357.2020.1805244. Epub 2020 Aug 10. PMID 32772828
• Lee K, Lee D, Hong S, Shin D, Jeong S, Shin H, Choi W, An S, Lee G. The relationship between sitting balance, trunk control and mobility with predictive for current mobility level in survivors of sub-acute stroke. PLoS One. 2021 Aug 5;16(8):e0251977. doi: 10.1371/journal.pone.0251977. eCollection 2021. PMID 34351943
• Sawa K, Amimoto K, Ishigami K, Miyamoto T, Setoyama C, Suzuki R, Nozomi K, Tamura M, Miyagami M. Efficacy of lateral truncal tilt training with a wedge on postural vertical and activities of daily living in recovery phase after stroke: A randomized crossover trial. NeuroRehabilitation. 2022;51(1):33-40. doi: 10.3233/NRE-210255. PMID 35275567

Identifiers

NCT: NCT07248618 · REC/02102

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗