NCT07209982

Brief Summary

What is this study about? This study compares two common ways of practicing walking and balance after a stroke: (1) dual-task training, where a person walks or balances while doing a second task (such as counting backward or carrying a light object), and (2) single-task training, where a person practices walking and balance without any extra task. The goal is to learn whether practicing with or without an added task is more practical and acceptable for people living with long-standing weakness on one side of the body (hemiplegia) after stroke. Why is this important? Many everyday activities-walking while talking, looking for a bus, or carrying a bag-require attention to more than one thing at a time. Some stroke survivors find this difficult. Training that safely mimics real-life multitasking may help therapists design better rehabilitation plans. Who can take part? Adults aged 45-65 years with a diagnosis of hemiplegic stroke who can walk without hands-on help may be eligible. People with other neurological conditions that affect walking, severe problems with understanding or communication, or recent serious medical/surgical issues will not be included. Additional screening will check safety for exercise. What will happen if I join? Participants are randomly assigned (like a coin toss) to one of two groups: Dual-task training group: walking/balance activities plus a simple cognitive or motor task. Single-task training group: the same walking/balance activities without any extra task. Both groups attend 60-minute sessions, three times per week, for six weeks at The University of Lahore Teaching Hospital or Sehat Medical Complex. A trained therapist supervises all sessions and adjusts difficulty gradually. Short rest breaks are provided. What will be measured? At baseline, 2 weeks, 4 weeks, and 6 weeks, an assessor who does not know the assigned group will record walking and balance using the Tinetti Performance-Oriented Mobility Assessment (POMA). Safety (such as any falls, dizziness, or discomfort) and attendance will also be recorded. What are the possible risks and benefits? Risks are similar to supervised physiotherapy: temporary muscle soreness, fatigue, or loss of balance. Therapists use safety measures (close supervision, stable equipment, and rest periods). Participants may experience the general benefits of structured rehabilitation (practice, education, and monitored activity). Taking part is voluntary, and usual care remains available. Privacy and cost Personal information is kept confidential and stored securely. There is no payment for participation. There are no charges for study-related therapy sessions. Time commitment About 18 sessions over 6 weeks, plus four short assessment visits. Contacts Study team members can answer questions at any time and will obtain written informed consent before any study procedures begin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

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

January 15, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 7, 2025

Completed
Last Updated

October 7, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

September 29, 2025

Last Update Submit

September 29, 2025

Conditions

Keywords

BalanceDual-task trainingGaitHemiplegic strokeRehablitation

Outcome Measures

Primary Outcomes (2)

  • Change in Balance Performance (Tinetti Balance Subscore)

    The balance component of the Tinetti Performance-Oriented Mobility Assessment (POMA), scored 0-16, with higher scores indicating better balance. Used to evaluate static and dynamic balance during standing and transitional tasks.

    Baseline, 2 weeks, 4 weeks, and 6 weeks

  • Change in Gait Performance (Tinetti Gait Subscore)

    The gait component of the Tinetti POMA, scored 0-12, assessing step length, symmetry, initiation, path deviation, and trunk stability during walking. Higher scores indicate better gait performance.

    Baseline, 2 weeks, 4 weeks, and 6 weeks

Study Arms (2)

Dual-Task Training (DTT)

EXPERIMENTAL

Participants receive structured gait and balance training combined with a concurrent secondary task. Secondary tasks include simple cognitive challenges (such as counting backward or naming objects) or light motor tasks (such as carrying a cup or tossing a ball). Sessions are 60 minutes, three times per week for six weeks, delivered under therapist supervision. Task difficulty is gradually increased while maintaining safety.

Behavioral: Dual-Task Training (DTT)

Single-Task Training (STT)

ACTIVE COMPARATOR

Participants receive the same dose of gait and balance training as the experimental arm, but without any concurrent secondary task. Exercises include level walking, directional changes, obstacle negotiation, and balance tasks on stable or unstable surfaces. Sessions are 60 minutes, three times per week for six weeks, supervised by a therapist. Difficulty is progressed through physical task demands only.

Behavioral: Single-Task Training (STT)

Interventions

This intervention combines gait and balance practice with a simultaneous secondary task to mimic real-world multitasking demands. Participants complete 60-minute sessions, three times per week for six weeks. Secondary tasks include simple cognitive activities (such as serial subtraction, word recall, or visual scanning) or light motor tasks (such as carrying an object or tossing a ball). Task complexity is increased gradually according to participant tolerance. All sessions are supervised by a trained physiotherapist, with rest breaks and safety precautions provided.

Also known as: Cognitive-Motor Dual-Task Training (CMDT)
Dual-Task Training (DTT)

This intervention provides gait and balance training without any added secondary tasks. Participants complete 60-minute sessions, three times per week for six weeks. Exercises include level walking, directional changes, obstacle negotiation, static and dynamic balance activities, and surface progressions (such as standing on foam). Progression is achieved by altering the physical task difficulty only. Sessions are supervised by a physiotherapist with safety measures in place and rest breaks as needed.

Single-Task Training (STT)

Eligibility Criteria

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

You may qualify if:

  • Patients diagnosed with hemiplegic stroke (Nam, 2023)
  • Both males and females patients
  • Participants ≤ 6 months poststroke (Nam, 2023)
  • Participants age between 45-65(Zhou et al., 2021)
  • Patients who are able to walk without assistance.(Joya, 2023) .

You may not qualify if:

  • History of other neurological conditions effecting mobility (Muzio et al., 2023).
  • Severe cognitive impairments or communication difficulties. (Liu et al., 2017)
  • Recent acute medical/surgical conditions unrelated to stroke.(Nam, 2023)
  • Other Systemic disease
  • Participants with severe hemiparesis who are unable to produce movement accurately (Zhang et al., 2022).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Lahore Teaching Hospital

Lahore, 54590, Pakistan

Location

Related Publications (1)

  • Pang MYC, Yang L, Ouyang H, Lam FMH, Huang M, Jehu DA. Dual-Task Exercise Reduces Cognitive-Motor Interference in Walking and Falls After Stroke. Stroke. 2018 Dec;49(12):2990-2998. doi: 10.1161/STROKEAHA.118.022157.

    PMID: 30571419BACKGROUND

MeSH Terms

Conditions

HemiplegiaStroke

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

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
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

September 29, 2025

First Posted

October 7, 2025

Study Start

January 15, 2025

Primary Completion

August 19, 2025

Study Completion

September 24, 2025

Last Updated

October 7, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations