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NCT Number: NCT07578948

Comparative Effects of Task Oriented Progressive Resistance Training and Modified Otago Exercise Among Stroke Patients.

Comparative Effects of Task Oriented Progressive Resistance Training and Modified Otago Exercise on Balance and Lower Limb Motor Function Among Stroke Patients.

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This study is active but is not currently recruiting participants.

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lahore, Punjab Province, 54000, Pakistan

About this study

Stroke is a clinical syndrome marked by the sudden onset of localized neurological indications that persist longer than 24 hours or result in death. This definition includes stroke both due to infarction and due to hemorrhage. Stroke is the second or third most common cause of death, one of the main causes of adult disability worldwide, and a global health problem. The remaining 80% are due to ischemic stroke which itself has a number of different subtypes, including large artery disease, cardio embolism, and small vessel disease. This study aims to evaluate the effects of Task Related Progressive Resistance Training and Modified Otago Exercises on balance and lower limb motor function in stroke patients.

A randomized controlled trial will be conducted over eleven months. Fifty-two stroke patients aged 45 to 65 years will be selected using non-probability convenient sampling technique. Participants will be randomly allocated into two groups using a lottery method. Group A will receive Task-Oriented Progressive Resistance Training which includes functional strengthening activities targeting lower limb muscles, while Group B will undergo Modified Otago Exercise Program which involves balance and strength exercises used to prevent fall in stroke. Interventions will be carried out over eight weeks, with assessments conducted pre- and post-intervention using the Berg Balance Scale (for balance), Fugl-Meyer Assessment (for lower limb motor function) and Mini Mental State Examination (for cognitive function). Data will be analysed using SPSS version 26, applying parametric or non-parametric tests based on data normality.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 45 to 65 years. (9)
  • Both genders male and female.
  • Clinically diagnosed with ischemic stroke.
  • Chronic stroke patients 6 to 10 months.
  • Presence of hemiparesis with mild to moderate motor deficits FMA-LE score 34.
  • Cognitive impairment MMSE score more than 26.
  • Ability to walk at least 10 meters with or without an assistive device

Exclusion criteria

  • Dementia or major neurocognitive disorder. (6)
  • Complete paralysis or unable to participate in active exercise. (11)
  • Patients with severe joint pain or arthritis are excluded due to reduce risk of injury and avoid confounding factors.
  • Recent fractures, or other musculoskeletal issues limiting exercise participation.
  • Suffering from physical diseases that prevent full participation in training.

Treatment and study plan

Modified otago exercise

Other

Warm up Head, neck, back extension, trunk, and ankle movement

  • Muscle strengthening:
  • Front knee (3)
  • Back knee
  • Side hip
  • Calf raises
  • Toe rises
  • Balance training:
  • Knee bends
  • Backward walking
  • Walk and turn
  • Sideways walk
  • Heel toe stand
  • Heel toe walk
  • One leg stand
  • Heel walk
  • Toe walk
  • Heel toe backward walk
  • Sit to stand
  • Stair walk

Other names: MOE

Task oriented progressive resistance training

Other

Standing and reaching in different directions for objects beyond arm's length

  • Sit to stand from various chair heights to strengthen lower limb extensors (3)
  • Stepping forward and backward on blocks of various heights
  • Stepping sideways on blocks of various heights
  • Forward stepping on blocks of various heights
  • Heel raise and lower in standing to strengthen plantar flexors (3)

Primary outcomes

  1. Fugl-Meyer Assessment (FMA)

    Time frame: baseline to 4rth week

    Fugl-Meyer Assessment of Lower Extremity (FMA-LE) total score interpretation ranges from 0 to 34, with higher scores indicating better motor function. Generally, a score of 34 represents normal function, while scores below 29 indicate varying degrees of disability. (15) All FMA-LE forms and subscales showed a high internal consistency (Cronbach's alpha>0.91).

  2. Berg Balance Scale (BBS)

    Time frame: Baseline to 4rth week

    The 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. (13) test-retest (ICC = 0.96; 95% CI, 0.93-0.98) and inter-rater (ICC = 0.93; 95% CI, 0.87-0.97) reliability was excellent

  3. Mini Mentel Scale (MMS)

    Time frame: baseline to 4rth week

    The Mini-Mental State Examination (MMSE) is a brief test used to screen for cognitive impairment, particularly in older adults. It assesses different aspects of cognitive function, including orientation, attention, memory, and language. The MMSE is scored on a scale of 0-30, with a score of 24 or higher generally considered normal. (17) The Mini-Mental State Examination (MMSE) generally demonstrates good internal consistency reliability, as indicated by Cronbach's alpha values ranging from 0.78 to 0.81.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparative Effects of Task Oriented Progressive Resistance Training and Modified Otago Exercise on Balance and Lower Limb Motor Function Among Stroke Patients.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 11, 2026
Registry last updated
May 11, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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