NCT07578948

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
1mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Apr 2025Jul 2026

Study Start

First participant enrolled

April 5, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2026

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

1.2 years

First QC Date

May 5, 2026

Last Update Submit

May 5, 2026

Conditions

Keywords

BalanceMotor functionModified otago exercisesTask oriented progressive resistance training

Outcome Measures

Primary Outcomes (3)

  • Fugl-Meyer Assessment (FMA)

    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).

    baseline to 4rth week

  • Berg Balance Scale (BBS)

    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

    Baseline to 4rth week

  • Mini Mentel Scale (MMS)

    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.

    baseline to 4rth week

Study Arms (2)

Modified otago exercises

EXPERIMENTAL
Other: Modified otago exercise

Task oriented progressive resistance training

ACTIVE COMPARATOR

Participants receive interventions 3 session per week for 4 weeks

Other: Task oriented progressive resistance training

Interventions

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

Also known as: MOE
Modified otago exercises

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)

Task oriented progressive resistance training

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (3)

  • Cekmece C, Sade I, Ozcan E, Balci S. Investigation of the effect of task-oriented occupational therapy on daily living activity performance in chronic stroke patients. Pak J Med Sci. 2024 Jul;40(6):1214-1218. doi: 10.12669/pjms.40.6.7954.

    PMID: 38952526BACKGROUND
  • Appelros P, Stegmayr B, Terent A. Sex differences in stroke epidemiology: a systematic review. Stroke. 2009 Apr;40(4):1082-90. doi: 10.1161/STROKEAHA.108.540781. Epub 2009 Feb 10.

    PMID: 19211488BACKGROUND
  • Murphy SJ, Werring DJ. Stroke: causes and clinical features. Medicine (Abingdon). 2020 Sep;48(9):561-566. doi: 10.1016/j.mpmed.2020.06.002. Epub 2020 Aug 6.

    PMID: 32837228BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Sabiha Arshad, Ms

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 11, 2026

Study Start

April 5, 2025

Primary Completion (Estimated)

June 3, 2026

Study Completion (Estimated)

July 6, 2026

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations