NCT06927505

Brief Summary

Stroke is an acute, focal neurological deficit attributed to vascular injury (infarction, hemorrhage) of the central nervous system. Trunk control, balance and posture are often impaired after stroke. Trunk and lower limb balance are vital for stroke patients as they significantly impact their functional independence, mobility, and safety. Training on unstable surfaces enhances core strength, balance, coordination, and proprioception. Bobath approach emphasizes the use of controlled, functional movements to enhance postural control and stability. This study aims to determine the comparative effectiveness of trunk training on unstable surfaces and bobath approach on trunk impairment, postural control and balance in stroke patients. The sample size will consist of 45 participants. Group A (unstable surfaces trunk training) and Group B (bobath based trunk training) will receive treatment session of 60 minutes for 3 days per week for 12 weeks. Data will be collected using various assessment tools, including the Trunk impairment scale, Berg balance scale and Postural Assessment Scale for Stroke (PASS) in stroke patients. Assessment will be carried out at baseline, 4th week, 8th week, 12th week and at 16th week after discontinuation of treatment. The data will be entered and analyzed using SPSS version 26. Repeated measures ANOVA will be performed for the with-in group analysis, whereas between-group analysis will be performed using one-way ANOVA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

December 20, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

April 7, 2025

Last Update Submit

August 18, 2025

Conditions

Keywords

Bobath ApproachStrokeBalancePosture

Outcome Measures

Primary Outcomes (1)

  • Trunk impairment scale (TIS)

    The Trunk Impairment Scale (TIS) is use to evaluate trunk control. It consists of 17 parameters and evaluates static and dynamic sitting balance and trunk coordination. A higher score indicates better performance. Its validity and reliability have been demonstrated in patients with stroke.

    4th week

Secondary Outcomes (2)

  • Berg Balance Scale (BBS)

    4th week

  • Postural Assessment Scale for Stroke (PASS)

    4th week

Other Outcomes (1)

  • MoCA (Montreal Cognitive Assessment)

    4th week

Study Arms (2)

Group A (bobath based trunk control training)

EXPERIMENTAL

Participants in this arm will perform bobath based trunk control training for 3 days per week.

Other: Bobath based trunk control training

Group B (unstable surface trunk training)

EXPERIMENTAL

Participants in this arm will perform unstable surface trunk training for 3 days per week.

Other: Unstable surface trunk training

Interventions

Participants in the Bobath based trunk training group will undergo a comprehensive intervention encompassing strengthening exercises, stretching exercises, and motor training. This group will experience a 60-minute session, including 40 minutes of Bobath based exercises along with 20 minutes routine physical therapy. 1. Strengthening the oblique abdominals 2. Weight Shifting (Side-to-Side \& Forward-Backward) 3. Pelvic Tilts 4. Functional strengthening of trunk extensors 5. Reaching 6. Latissimus dorsi stretching exercise 7. Bridging 8. Trunk rotation (supine and standing position) 9. Sitting to Standing Transitions (with emphasis on trunk control) 10. Standing Weight Shifts There will be a rest of 1 minute between each set of exercise. Progression of exercises with increase in intensity and resistance.

Group A (bobath based trunk control training)

This group will receive 60-minute training session that consists of 40 minutes of unstable surfaces exercises and 20 minutes of routine physical therapy 3 days per week for a total of 12 weeks. Hook-lying position: (1) Abdominal draw-in maneuver with ball under the buttocks. (2) Abdominal muscles isometric contraction. (3) Bridging combining with abdominal draw-in maneuver. Each exercise will be performed with 5-8 repetitions. Sitting: (1) Seated balance (2) Weight shifting e.g. anterior, posterior, lateral (3) Pelvic tilts e.g. anterior and posterior tilt (4) Trunk flexion, extension and lateral flexion on both sides (5) trunk rotation on both sides (6) Reaching e.g. lateral, forward and upward reach (7) Marching while seated Each exercise will be performed with 5-8 repetitions.

Group B (unstable surface trunk training)

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects fulfilling given criteria will be included in this study:
  • Subjects with first onset of stroke.
  • Minimum duration for onset of stroke is (3-6) months.
  • Subjects aged 25 to 65 years.
  • Both male and female genders.
  • Patients who are able to follow command.
  • Patients who are able to sit independently for 30 seconds.
  • MoCA (Montreal Cognitive Assessment) of ≥ 26/30 indicating intact Cognition.

You may not qualify if:

  • Participants having given criteria will be excluded from this study:
  • Patient with recurrent attacks.
  • Patients who are not able to follow command.
  • Patients who have severe limitations in passive range of motion at lower extremities.
  • Patients undergoing any other balance training protocol.
  • Patients with contraindications to exercise, preexisting neurological disorders, severe communication impairments and history of diagnosed musculoskeletal disorders.
  • Patients who are unable to sit independently for 30 seconds.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faisal Masood Teaching Hospital

Sargodha, Punjab Province, 40100, Pakistan

Location

Related Publications (6)

  • Silva PB, Mrachacz-Kersting N, Oliveira AS, Kersting UG. Effect of wobble board training on movement strategies to maintain equilibrium on unstable surfaces. Hum Mov Sci. 2018 Apr;58:231-238. doi: 10.1016/j.humov.2018.02.006. Epub 2018 Mar 12.

    PMID: 29499471BACKGROUND
  • Sag S, Buyukavci R, Sahin F, Sag MS, Dogu B, Kuran B. Assessing the validity and reliability of the Turkish version of the Trunk Impairment Scale in stroke patients. North Clin Istanb. 2018 Aug 14;6(2):156-165. doi: 10.14744/nci.2018.01069. eCollection 2019.

    PMID: 31297483BACKGROUND
  • Lee PY, Huang JC, Tseng HY, Yang YC, Lin SI. Effects of Trunk Exercise on Unstable Surfaces in Persons with Stroke: A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Dec 7;17(23):9135. doi: 10.3390/ijerph17239135.

    PMID: 33297451BACKGROUND
  • Pathak A, Gyanpuri V, Dev P, Dhiman NR. The Bobath Concept (NDT) as rehabilitation in stroke patients: A systematic review. J Family Med Prim Care. 2021 Nov;10(11):3983-3990. doi: 10.4103/jfmpc.jfmpc_528_21. Epub 2021 Nov 29.

    PMID: 35136756BACKGROUND
  • Arienti C, Lazzarini SG, Pollock A, Negrini S. Rehabilitation interventions for improving balance following stroke: An overview of systematic reviews. PLoS One. 2019 Jul 19;14(7):e0219781. doi: 10.1371/journal.pone.0219781. eCollection 2019.

    PMID: 31323068BACKGROUND
  • Van Criekinge T, Hallemans A, Herssens N, Lafosse C, Claes D, De Hertogh W, Truijen S, Saeys W. SWEAT2 Study: Effectiveness of Trunk Training on Gait and Trunk Kinematics After Stroke: A Randomized Controlled Trial. Phys Ther. 2020 Aug 31;100(9):1568-1581. doi: 10.1093/ptj/pzaa110.

    PMID: 32542356BACKGROUND

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Both participants and outcome assessor were blinded in this study
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2025

First Posted

April 15, 2025

Study Start

December 20, 2024

Primary Completion

July 30, 2025

Study Completion

July 30, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations