StrokeNCT06927505
Comparative Effects of Unstable Surfaces and Bobath on Trunk Impairment, Posture and Balance in Post Stroke Patients.
A study testing Unstable surface trunk training in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Unstable surface trunk training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Dec 2024to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Faisal Masood Teaching Hospital
Sargodha, Punjab Province, 40100
About this study
Official title: Comparative Effects of Unstable Surfaces and Bobath Based Trunk Exercises on Trunk Impairment, Postural Control and Balance in Stroke Patients.
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Bobath based trunk control training, Unstable surface trunk training
- Keywords
- Bobath Approach, Stroke, Balance, Posture
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bobath based trunk control trainingOther
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.
Unstable surface trunk trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (bobath based trunk control training) | Experimental | Participants in this arm will perform bobath based trunk control training for 3 days per week. Receives: 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. Receives: Other: Unstable surface trunk training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4th week
Secondary outcomes (2)
Berg Balance Scale (BBS)
BBS is postural balance scale containing 14 items including standing and sitting unsupported, reaching forward, and placing the alternating foot on a stool. Administering the BBS takes approximately 15 min. Each of the 14 items are scored on a 5-level ordinal scale from 0 ("unable to perform or requiring help") to 4 ("normal performance"), thus providing a potential maximum score of 56 points.
Measured: 4th week
Postural Assessment Scale for Stroke (PASS)
PASS is a scale that makes postural evaluation of patients with stroke in three different positions (i.e. lying, sitting, and standing). The scale consists of 12 items. It is a 4-point type scoring ranging from 0 to 3 points. Total scoring varies between 0 and 36. There are two subscales: "maintaining posture" and "changing posture". Both sections can be scored separately and the sum of these scores gives the total score.
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start20 Dec 2024
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927505
- Sponsor's protocol ID
- REC/0261 Qaila Tariq
- Status last verified
- Aug 2025
- First submitted
- 7 Apr 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29499471Sag 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.
PubMed 31297483Lee 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.
PubMed 33297451Pathak 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.
PubMed 35136756Arienti 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.
PubMed 31323068Van 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.
PubMed 32542356
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Unstable Surfaces and Bobath Based Trunk Exercises on Trunk Impairment, Postural Control and Balance in Stroke Patients.
- ClinicalTrials.gov ID
- NCT06927505
- Acronym / sponsor ID
- REC/0261 Qaila Tariq
- Conditions
- Stroke
- Keywords
- Bobath Approach, Stroke, Balance, Posture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 15 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (bobath based trunk control training) | Experimental | Other: Bobath based trunk control trainingParticipants in this arm will perform bobath based trunk control training for 3 days per week. |
| Group B (unstable surface trunk training) | Experimental | Other: Unstable surface trunk trainingParticipants in this arm will perform unstable surface trunk training for 3 days per week. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bobath based trunk control trainingParticipants 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. | Other | Group A (bobath based trunk control training) |
| Unstable surface trunk trainingThis 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. | Other | Group B (unstable surface trunk training) |
Primary outcome
Trunk impairment scale (TIS)
Time frame: 4th week
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.
2 secondary outcomes
Berg Balance Scale (BBS)
Time frame: 4th week
Postural Assessment Scale for Stroke (PASS)
Time frame: 4th week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Background: PubMed 29499471Silva 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.
- Background: PubMed 31297483Sag 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.
- Background: PubMed 33297451Lee 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.
- Background: PubMed 35136756Pathak 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.
- Background: PubMed 31323068Arienti 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.
- Background: PubMed 32542356Van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aruba Saeed, PhD principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unstable surface trunk 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 22 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk impairment scale (TIS) (time frame: 4th week). 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 NCT06927505, which also lists 6 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 22 Aug 2025.