Sub-acute StrokeNCT07576166
Combined Effects of Rhythmic Breathing and Balance Training on Balance and Trunk Control in Stroke Patients
A study testing rhythmic breathing exercise, Balance training and conventional physical therapy in people with Sub-acute Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
The goal of this study is to evaluate the combined effects of rhythmic breathing and balance training on balance, trunk control and postural control in patients with sub-acute stroke. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Sub-acute Stroke
- What is being tested?
- rhythmic breathing exercise, Balance training and conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 5 May 2026to 15 Jul 2026
- Phase
- Interventional
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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45-65 years old
- Either gender
- Sub-acute stroke (3-6months)
- The cognition level of patient according to Mini Mental Score Examination will be >24
- The trunk control of patient based on Trunk Impairment score is 20 or less than 23
- First-ever ischemic stroke
- Ability to tolerate at least 60 min exercise according to berg scale scoring less than 8
- Agree to sign the written informed consents
Who cannot join
- • Severe visual hemianopsia
- Acute diseases of the heart, brain, kidney and other organs
- Sensory neuropathy such as diabetic neuropathy
- Balance dysfunction due to other neurological disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Dr. Faisal Masood Teaching Hospital Sargodha
Sargodha, Punjab Province, 40100
Hira Jabeen
Anam Maqbool, MS-PT
About this study
Official title: Combined Effects of Rhythmic Breathing Exercises and Balance Training on Balance and Trunk Control in Patients With Stroke
The goal of this study is to evaluate the combined effects of rhythmic breathing and balance training on balance, trunk control and postural control in patients with sub-acute stroke. The main questions it aims to answer are:
- Will there be a difference in combined effects of rhythmic breathing exercises and balance training on balance and trunk control in patients with stroke?
- Will there be no difference in combined effects of rhythmic breathing exercises and balance training on balance and trunk control in patients with stroke? The participants will be evenly divided into two groups,
- the experimental group will receive rhythmic breathing exercises along with balance training and conventional physical therapy
- the control group will only receive balance training and physical therapy. Both the groups will perform their respective exercises for 60 minutes, 3 days a week for consecutive 8 weeks.
Read the detailed description
The aim of this study is to evaluate the combined effects of rhythmic breathing and balance training on balance, trunk control and postural control in sub-acute stroke patients. It will be a single blinded randomized controlled trial. Non-probability convenience sampling will be used to recruit 50 patients aged 45-65 years from Dr. Faisal Masood Teaching Hospital Sargodha. Through the computerized generator table method of randomization, the allocated patients will be evenly divided into two groups, the experimental group undergoing Rhythmic Breathing exercises along with Balance training and conventional physical therapy and the control group only balance training and physical therapy. Both the groups will perform their respective exercises for 60 minutes 3 days a week for consecutive 8 weeks. The stroke patients will be assessed at the baseline and post intervention with outcome measuring tools. Balance will be assessed through Berg Balance Scale (BBS), trunk control will be assessed through Trunk Impairment Scale(TIS), and postural control will be assessed through Postural Assessment Scale for Stroke (PASS). Data will be analyzed in SPSS version 27.0.
- Conditions
- Sub-acute Stroke
- Being tested
- rhythmic breathing exercise, Balance training, conventional physical therapy
- Keywords
- Rhythmic breathing exercises, Balance training, Berg balance scale, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhythmic breathing exerciseOther
Also called Balance training, conventional physical therapy
The protocol for Rhythmic Breathing Exercises (22) is given as:
Position: Supine with knees and hips slightly flexed, in a comfortable position Inhalation Phase: Deep inhalation with conscious outward movement of the abdomen; pause and hold for 10 seconds Exhalation Phase: Slow exhalation with conscious abdominal retraction, maintaining a slow and deep rhythm Hand Placement: One hand on the chest, one on the abdomen to monitor movement Breathing Cue: Only the hand on the abdomen should move during breathing; the chest should remain still Repetitions: 3 sets of 10 repetitions Rest Between Sets: 1 minute Total Duration: Limited to 10 minutes
Balance trainingOther
Sitting-to-Standing: Performed using a stool with 3 sets of 5 repetitions Lateral Stepping: Walk 3 meters back and forth sideways with 3 sets of 5 repetitions Forward and Backward Stepping: 5 times with right leg stepping first, 5 times with left leg stepping first with 3 sets of 5 repetitions Forward Walking: Walk 3 meters back and forth, turn right at one end and left at the other wit 3 sets of 5 repetitions Stepping Up and Down: 5 times with right leg stepping first, 5 times with left leg stepping first with 3 sets of 5 repetitions Throwing and Catching Ball: Using a soft volleyball with 3 sets of 5 repetitions
conventional physical therapyOther
Warm-Up: Active/passive ROM exercises for upper and lower limbs, 3 days/week for 10-15 minutes Trunk Control Exercises: Bridging, pelvic tilts, seated trunk rotations, reaching tasks with 3 sets of 5 repetitions for 3 days/week for 20 minutes Strengthening Exercises: Resistance band work for lower limb extensors, upper limb flexors with 3 sets of 5 repetitions for 3 days/week for 15-20 minutes Stretching: Hamstrings, calf, hip flexors, upper trapezius with 3 sets of 5 repetitions for 3 days/week for 10 minutes Postural Control Training: Use of Swiss ball, sitting on unstable surfaces, dual-task exercises with 3 sets of 5 repetitions for 3 days/week for 15-20 minutes Gait Training: Parallel bar walking, overground ambulation, obstacle walking 3 sets of repetitions for 3 days/week for 15-20 minutes Cool Down: Deep breathing, guided relaxation with 3 days/week for 5-10 minutes Education: Fall prevention, safe transfers, home exercise program with weekly session for 10-15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Rhythmic breathing exercises | Experimental | Not described Receives: Other: rhythmic breathing exercise; Other: Balance training; Other: conventional physical therapy |
| Balance training and conventional physical therapy | Active comparator | Not described Receives: Other: Balance training; Other: conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale
The BBS is a 14-item measure used to assess functional mobility, static balance, and dynamic balance excluding ambulation. However, BBS scores have also been correlated with stroke patient's motor and functional performance. Scores range on an ordinal scale from zero (indicating need for assistance to minimally perform the task) to four (indicating independent performance of the task); with a maximum possible score of 56. Historically, a score below 45/56 is typically indicative of increased fall risk.
Measured: Baseline and 8th week
Trunk Impairment Scale
The original version of Trunk Impairment Scale (TIS) was developed by in 2004. It comprises 17 items (scored on a 2, 3 or 4-point ordinal scale) and evaluates static and dynamic sitting, balance and trunk coordination. The total score ranges from minimum 0 to maximum 23 points, a higher score indicating a better performance.
Measured: Baseline and 8th week
Postural Assessment Scale for Stroke
The Postural Assessment Scale for Stroke (PASS) is a scale developed specifically for stroke patients. It examines the patient's ability to maintain or change a given lying, sitting or standing posture, is easy to administer in the clinic and applicable to all patients, even those with very poor postural performance. It contains 12 items of varying difficulty for assessing ability to maintain or change a given lying, sitting, or standing posture. The items are assessed on a 4 level (0-3 point) rating scale. The score ranges from a minimum of 0 (worst performance) to a maximum of 36 (best performance).
Measured: Baseline and 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start5 May 2026
- Primary completion5 Jul 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sub-acute StrokeStudies of the same condition, open and under way.
- 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, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hira Jabeen, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07576166
- Sponsor's protocol ID
- REC/RCR & AHS/25/0233
- Status last verified
- May 2026
- First submitted
- 4 May 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No