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NCT Number: NCT07576166

Combined Effects of Rhythmic Breathing and Balance Training on Balance and Trunk Control in Stroke Patients

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.

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Faisal Masood Teaching Hospital Sargodha

Sargodha, Punjab Province, 40100, Pakistan

Location status: Recruiting

Location contact

Anam Maqbool, MS-PT

PRINCIPAL_INVESTIGATOR

Hira Jabeen

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • • 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

Treatment and study plan

rhythmic breathing exercise

Other

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

Other names: Balance training, conventional physical therapy

Balance training

Other

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 therapy

Other

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

Primary outcomes

  1. Berg Balance Scale

    Time frame: Baseline and 8th week

    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.

  2. Trunk Impairment Scale

    Time frame: Baseline and 8th week

    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.

  3. Postural Assessment Scale for Stroke

    Time frame: Baseline and 8th week

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Imran Amjad, Phd

CONTACT

[email protected]

033324390125

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Combined Effects of Rhythmic Breathing Exercises and Balance Training on Balance and Trunk Control in Patients With Stroke

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 8, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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