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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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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
  • Dr. Faisal Masood Teaching Hospital Sargodha

    Sargodha, Punjab Province, 40100

    Hira Jabeen

    Anam Maqbool, MS-PT

    Recruiting

Other trials in Pakistan

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.

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 groups in NCT07576166
Study groupRoleWhat they receive
Rhythmic breathing exercisesExperimentalNot described
Receives: Other: rhythmic breathing exercise; Other: Balance training; Other: conventional physical therapy
Balance training and conventional physical therapyActive comparatorNot 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.

  1. 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

  2. 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

  3. 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.

  1. First posted8 May 2026
  2. Study start5 May 2026
  3. Primary completion5 Jul 2026 (estimated)
  4. Study completion15 Jul 2026 (estimated)

Resources

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)
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

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