Clinical trial NCT06927505: Comparative Effects of Unstable Surfaces and Bobath on Trunk Impairment, Posture and Balance in Post Stroke Patients.
Official title: Comparative Effects of Unstable Surfaces and Bobath Based Trunk Exercises on Trunk Impairment, Postural Control and Balance in Stroke Patients.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Bobath approach, Stroke, Balance, Posture, Trunk
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 58
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Trunk control and sitting balance are often impaired after stroke. Patients who are able to sit independently in the early stages after a stroke seem to have greater chances of walking independently at discharge. These impairments are characterized by a diminished siting balance, trunk coordination and muscle strength. In contrast to the extremities, the trunk is bilaterally impaired. Therefore, both the paretic and non-paretic side of the trunk are characterized by reduced activity levels, delayed onset times, and diminished synchronization of the trunk musculature. Therefore, knowledge concerning changes in trunk biomechanics after stroke should be increased so that they can be addressed adequately in therapy. Impaired balance and postural control are an important clinical feature after stroke.

So, incorporating exercises aiming to improve trunk control early in a stroke rehabilitation program should be beneficial for regaining activities of daily living. Trunk rehabilitation is an effective strategy for improving trunk control and sitting balance in addition to finding carryover effects on standing balance and mobility. Swiss ball is widely used for recreational \& rehabilitation training programs. As the liable surface of the Swiss ball provides greater challenge for the dynamic balance, co-ordination and trunk control. Swiss exercises facilitate postural control, trunk control, sitting \& dynamic balance control by reducing impaired balance \& co-ordination by maintaining interaction between nervous system, musculoskeletal system \& contextual effects. The Bobath Concept is referred to as the neuro-developmental technique (NDT) worldwide. Stroke patients shall actively participate in exercises assisted by the therapist. Therapists use key points of handling and reflex inhibiting patterns for performing exercises. Bobath approach works on the different types of movement dysfunctions and is based on the active involvement of the patients so that they can develop motor control. This type of therapy incorporates improved functional control and independence. NDT/Bobath concept has been recognized as a treatment for stroke patients with movement dysfunctions. Despite numerous studies investigating rehabilitation techniques for post-stroke patients, there is a notable gap in directly comparing the effects of unstable surface and Bobath-based trunk exercises on trunk impairment, postural control, and balance. Literature is also available about the effectiveness of each intervention in isolation, but according to researcher's knowledge, studies on the comparative effect of these two interventions on trunk control, posture and balance and determining the long-term effects of both types of intervention in stroke have not been conducted yet. So, this study aims to compare the effects of unstable surfaces and Bobath approach on trunk coordination, balance and functional enhancement in patients with stroke.

Eligibility criteria: Inclusion Criteria:

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 35 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.
* Mini Mental Status Exam of ≥ 24/30 indicating intact Cognition.

Exclusion Criteria:

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, a body mass index \>31 kg/m2, and history of diagnosed musculoskeletal disorders.
* Patients who are unable to sit independently for 30 seconds.

Primary outcomes:
measure: Trunk impairment scale (TIS)
timeFrame: 4th week
Secondary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: 4th week
measure: Postural Assessment Scale for Stroke (PASS)
timeFrame: 4th week
Other outcomes:
measure: Modified Ashworth Scale
timeFrame: 4th week
measure: MoCA (Montreal Cognitive Assessment)
timeFrame: 4th week
Locations:
Study officials:
affiliation: Riphah International University
name: Aruba Saeed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.