NCT07249658

Brief Summary

This randomized controlled trial aims to determine the combined effect of power training and high-intensity gait training on functional mobility and locomotion following chronic stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 21, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 25, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2026

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

November 18, 2025

Last Update Submit

March 25, 2026

Conditions

Keywords

gait trainingstrengthpowerfunctional mobilityambulation

Outcome Measures

Primary Outcomes (5)

  • five times sit-to-stand test (FTSST)

    The FTSST developed by Csuka and McCarty (1985) is a very reliable tool to measure sitting and standing performance as well as lower limb muscle strength and balance. It is a single-item test where the participant is required to rise from a chair and sit down five consecutive times as quickly as possible without using the arms. The score is recorded as the total time taken in seconds to complete the task.

    6 weeks

  • Tmed Up and Go Test

    The Timed Up and Go (TUG) is a commonly used outcome measure that can assess activity limitations in the ICF model by examining the patient's ability to ambulate and perform transfers.

    6 weeks

  • 10 meter Walk Test

    The 10-Meter Walk Test was developed as a simple, quick, and reliable measure of gait speed. It is a single-item test where the participant walks 10 meters, with timing recorded for the middle 6 meters to exclude acceleration and deceleration phases. It is widely used to assess functional mobility, walking ability, and community ambulation in populations such as stroke, Parkinson's disease, geriatrics, and rehabilitation patients.

    6 weeks

  • Barthel index

    Assesses the level of independence in daily activities, such as feeding, bathing, and mobility, in individuals with physical disabilities. Literature showed strong criterion-related validity against the BI, with high reliability. This scoring system may become a convenient tool, allowing anyone to assess ADL.

    6 weeks

  • Functional Gait Assessment

    Measures balance and gait under various challenging conditions to assess fall risk and overall gait stability. The Functional Gait Assessment is a reliable, valid tool. It is composed of 10 items, each scored 0-3 (0 = severe impairment, 3 = normal performance). Maximum score = 30. Lower scores indicate higher risk of falls; ≤22/30 is often used as a cutoff for increased fall risk.

    6 weeks

Study Arms (3)

Experimental: power training + high-intensity gait training

EXPERIMENTAL

This group will be given a combined program that comprises gait training and lower-limb power training, three times a week. The gait component will consist of overground walking at increased intensity and treadmill training whilst using a safety harness. At the initial stage, treadmill (1.5-2.0 mph) for a duration of 2 sets,3 minutes, and 10-minute overground moderate-intensity walking is offered with frequent rests. The intensity will be gradually increased throughout the program, with an increase in speeds on the treadmill to 2.0 mph (2.5 mph or 3.0 mph) (two sets of three minutes, then three sets of 3-4 minutes, and finally 5-10 minutes at moderate and high intensity) and overground walking (10-15 min to up to 20 min at high intensity).

Other: power training + high-intensity gait training

Control 1: power training

ACTIVE COMPARATOR

Individuals in the power training group will also train three times a week, including lower-limb resistance and functional strength work, applying a focus on explosive concentric effort. The exercise will consist of 3 sets (or 6 repetitions of stepping backward over a hurdle, warming up in sitting knee extension with resistance band, marching in a seat with a load on the ankle, transferring sit to stand, and hopping up on the box 46 inch). The number of sets will be increased as they are tolerated, beginning with 3 sets to 4 sets and ultimately up to 5 sets of each exercise as tolerated as the training progresses. The intensity will be progressed by raising the resistance ( box height) and performance speed.

Other: power training

Control 2: High-intensity gait training

ACTIVE COMPARATOR

This group will receive high-intensity gait training three days per week, taking into consideration both treadmill gait in a safety harness and overground gait. Initial training will start with a treadmill speed of 1.5 2.0 mph, two sets/3 minutes each, and 15 minutes overground walking at moderate intensity, and rest breaks when necessary. The progression will entail a gradual increase in the speeds on the treadmill to 2.0-2.5 mph (three sets of 3 minutes) and subsequently to 2.5 3.0 mph (three sets of 3 4 minutes) with the overground walking time extended to 15-20 mins and subsequently to 20 minutes at greater intensities.

Other: high-intensity gait training

Interventions

The members of this group will receive high-intensity gait training three days per week, taking into consideration both treadmill gait in a safety harness and overground gait. Initial training will start with a treadmill speed of 1.5 2.0 mph, two sets/3 minutes each, and 15 minutes overground walking at moderate intensity, and rest breaks when necessary. The progression will entail a gradual increase in the speeds on the treadmill to 2.0-2.5 mph (three sets of 3 minutes) and subsequently to 2.5 3.0 mph (three sets of 3 4 minutes) with the overground walking time extended to 15-20 mins and subsequently to 20 minutes at greater intensities.

Control 2: High-intensity gait training

Individuals in the power training group will also train three times a week, including lower-limb resistance and functional strength work, applying a focus on explosive concentric effort. The exercise will consist of 3 sets (or 6 repetitions of stepping backward over a hurdle, warming up in sitting knee extension with resistance band, marching in a seat with a load on the ankle, transferring sit to stand, and hopping up on the box 46 inch). The number of sets will be increased as they are tolerated, beginning with 3 sets to 4 sets and ultimately up to 5 sets of each exercise as tolerated as the training progresses. The intensity will be progressed by raising the resistance ( box height) and performance speed.

Control 1: power training

This group will be given a combined program that comprises gait training and lower-limb power training, which will take place three times a week. The gait component will consist of overground walking at increased intensity and treadmill training whilst using a safety harness. At the initial stage, treadmill (1.5-2.0 mph) for a duration of 2 sets,3 minutes, and 10-minute overground moderate-intensity walking is offered with frequent rests. The intensity will be gradually increased throughout the program, with an increase in speeds on the treadmill to 2.0 mph (2.5 mph or 3.0 mph) (two sets of three minutes, then three sets of 3-4 minutes, and finally 5-10 minutes at moderate and high intensity) and overground walking (10-15 min to up to 20 min at high intensity).

Experimental: power training + high-intensity gait training

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 75 years of age
  • more than ≥6 months of stroke onset
  • first-ever unilateral ischemic stroke
  • walking 10 meters independently with or without an assistive device
  • being an independent ambulator (Functional Ambulation category \>3)

You may not qualify if:

  • people with a history of mental/cognitive illness
  • combination with peripheral neuropathy
  • having resting blood pressure above 160/100 mmHg even after taking medications;
  • hemorrhagic stroke
  • cardiovascular comorbidity
  • any musculoskeletal condition that prevents or limits the participants from doing resistance training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National institute of Rehabilitation Medicine, NIRM

Islamabad, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Fatima Khan, MS-NMPT*

    Riphah International Unversity

    PRINCIPAL INVESTIGATOR
  • Arshad Nawaz Malik, PhD Rehab

    Riphah International Unversity

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 18, 2025

First Posted

November 25, 2025

Study Start

August 21, 2025

Primary Completion

February 21, 2026

Study Completion

February 21, 2026

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations