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StrokeNCT07248618

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

A study testing Trunk Training Exercises and Lateral Truncal Tilt Balance Training in people with Stroke, run by Riphah International University at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 75 years
Conditions the study is for
Stroke
What is being tested?
Trunk Training Exercises and Lateral Truncal Tilt Balance Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 sitePakistan
Study dates
17 Oct 2024to 30 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hafsa Fayyaz, MS-NMPT contact

03229425544

hafsa.fayyaz78690@gamil.com

Pakistan1 site, 1 recruiting
  • Jinnah hospital

    Lahore, Punjab Province, 54550

    Hafsa Fayyaz, MS-NMPT, 0322-9425544, hafsa.fayyaz78690@gmail.com

    Fatima Tariq, MS-NMPT, O334-4255033, fatima.tariq@riphah.edu.pk

    Recruiting

Other trials in Pakistan

About this study

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

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.

Read the 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
Being tested
Trunk Training Exercises, Lateral Truncal Tilt Balance Training
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trunk Training ExercisesOther

    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 TrainingOther

    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.

Study groups in NCT07248618
Study groupRoleWhat they receive
Trunk Training ExercisesActive comparatorCore Stabilization Exercises, dynamic trunk exercises, bridging exercises
Receives: Other: Trunk Training Exercises
Lateral Truncal Tilt Balance TrainingExperimentalSeated lateral tilts, Standing Lateral Weight Shifts, balance board tilts, Stability Ball Exercises, lateral Reaches on Unstable Surface
Receives: Other: Lateral Truncal Tilt Balance Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Timed up and go test (TUG)

    The Timed Up and Go (TUG) test is a simple and widely used assessment to evaluate a person's mobility, balance, and risk of falling, particularly in older adults and individuals with neurological conditions like stroke. A time of under 10 seconds is typically considered normal for healthy adults, while times over 12-14 seconds may indicate a higher risk of falls and impaired mobility. It has good validity and reliability ranging from 0.80-0.83

    Measured: 1-2 min

Secondary outcomes (1)
  1. Berg balance scale (BBS)

    . The scale consists of 14 functional tasks, such as standing from a seated position, reaching forward, standing with eyes closed, and turning 360 degrees. Each task is scored on a 5-point scale from 0 (unable to perform) to 4 (normal performance), yielding a maximum score of 56, with lower scores indicating a greater risk of falling (20).

    Measured: 15 to 20 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2025
  2. Study start17 Oct 2024
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion30 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07248618
Sponsor's protocol ID
REC/02102
Status last verified
Nov 2025
First submitted
18 Nov 2025
Last updated
25 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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: 10.1080/10749357.2021.2016099. Epub 2022 Jan 7.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 35275567
  • De Luca A, Squeri V, Barone LM, Vernetti Mansin H, Ricci S, Pisu I, Cassiano C, Capra C, Lentino C, De Michieli L, Sanfilippo CA, Saglia JA, Checchia GA. Dynamic Stability and Trunk Control Improvements Following Robotic Balance and Core Stability Training in Chronic Stroke Survivors: A Pilot Study. Front Neurol. 2020 Jun 17;11:494. doi: 10.3389/fneur.2020.00494. eCollection 2020.

    PubMed 32625162
  • Shalash A, Fayed ZY, Hamid E, Radwan H, Nada MA, Eid M, Abdel Ghany WA. Outcome of pallidal stimulation of idiopathic generalized dystonia with predominant mobile truncal dystonia: case report. Int J Neurosci. 2022 May;132(5):429-433. doi: 10.1080/00207454.2020.1818743. Epub 2020 Sep 16.

    PubMed 32886009
  • Tamura S, Miyata K, Kobayashi S, Takeda R, Iwamoto H. The minimal clinically important difference in Berg Balance Scale scores among patients with early subacute stroke: a multicenter, retrospective, observational study. Top Stroke Rehabil. 2022 Sep;29(6):423-429. doi: 10.1080/10749357.2021.1943800. Epub 2021 Jun 25.

    PubMed 34169808
  • Jin X, Wang L, Liu S, Zhu L, Loprinzi PD, Fan X. The Impact of Mind-body Exercises on Motor Function, Depressive Symptoms, and Quality of Life in Parkinson's Disease: A Systematic Review and Meta-analysis. Int J Environ Res Public Health. 2019 Dec 18;17(1):31. doi: 10.3390/ijerph17010031.

    PubMed 31861456

Questions about this trial

What is this clinical trial studying?

A study testing Trunk Training Exercises and Lateral Truncal Tilt Balance Training in people with Stroke, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hafsa Fayyaz, MS-NMPT (03229425544, hafsa.fayyaz78690@gamil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Timed up and go test (TUG) (time frame: 1-2 min). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07248618, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.

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