NCT07248618

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

November 25, 2025

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

November 18, 2025

Last Update Submit

November 18, 2025

Conditions

Outcome Measures

Primary Outcomes (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

    1-2 min

Secondary Outcomes (1)

  • Berg balance scale (BBS)

    15 to 20 min

Other Outcomes (1)

  • Trunk impairment scale (TIS)

    upto 20 min

Study Arms (2)

Trunk Training Exercises

ACTIVE COMPARATOR

Core Stabilization Exercises, dynamic trunk exercises, bridging exercises

Other: Trunk Training Exercises

Lateral Truncal Tilt Balance Training

EXPERIMENTAL

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

Other: Lateral Truncal Tilt Balance Training

Interventions

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.

Trunk Training Exercises

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.

Lateral Truncal Tilt Balance Training

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah hospital

Lahore, Punjab Province, 54550, Pakistan

RECRUITING

Related Publications (12)

  • 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: 37468952BACKGROUND
  • 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: 32837228BACKGROUND
  • 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: 34886530BACKGROUND
  • 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: 32574524BACKGROUND
  • 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.

    PMID: 34994302BACKGROUND
  • 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: 32772828BACKGROUND
  • 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: 34351943BACKGROUND
  • 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: 35275567BACKGROUND
  • 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.

    PMID: 32625162BACKGROUND
  • 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.

    PMID: 32886009BACKGROUND
  • 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.

    PMID: 34169808BACKGROUND
  • 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.

    PMID: 31861456BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Aruba Saeed, Phd*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hafsa Fayyaz, MS-NMPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start

October 17, 2024

Primary Completion

November 30, 2025

Study Completion

December 30, 2025

Last Updated

November 25, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations