NCT07754110

Brief Summary

Strokes frequently affect motor function, balance, and coordination, reducing independence. HABIT-ILE combines upper and lower limb exercises to improve coordination and balance. Objective To determine the effectiveness of HABIT-ILE on balance and coordination among stroke patients. we used randomized controlled trails (two-arm parallel design) on 44 people who were allocated evenly into two groups using purposive sampling. The Berg Balance Scale, Finger-to-Nose Test, and 6-Minute Walk Test were administered during a six-month period at HHRD Center, Mansehra. Data was analyzed using SPSS 25 with repeated measures ANOVA and the Shapiro-Wilk test to ensure normality

Trial Health

77
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress7%
Jul 2026Feb 2027

Study Start

First participant enrolled

July 30, 2026

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 5, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2027

Expected
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

August 10, 2026

Status Verified

August 1, 2026

Enrollment Period

6 months

First QC Date

August 5, 2026

Last Update Submit

August 5, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • Finger to nose test

    The finger-to-nose test (FNT) is a basic and simple physical examination that has been conventionally used to examine cerebellar function. In the FNT, patients are asked to alternately touch their own nose and the evaluator's stationary or moving finger while lying supine, or while sitting or standing. The Finger-to-Nose-Test measures smooth, coordinated upper-extremity movement by having the examinee touch the tip of his or her nose with his or her index finger. On one variation of the test, the examiner holds out his or her finger, about an arm's length from the patient. The patient is instructed to touch the examiner's finger, then his or her own nose. After several successful trials, the patient is then asked to repeat the action more quickly. Moving the target finger can increase the difficulty of the task. This test is part of a comprehensive neurological examination. It is typically employed as part of coordination testing. The examiner looks for evidence of intention tremor or

    6 Weeks

  • berg balance scale

    The Berg Balance Scale is a testing tool with high validity and reliability used to measure balance. Balance gives an individual the ability to achieve physical movement and further carry out the activities of daily living. A five-point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 0-56. Score of 41-56 = low fall risk, 21-40 = medium fall risk, 0-20 = high fall risk. The Berg Balance Scale has a high relative reliability with interrater reliability estimatedat0.97 (95% CI 0.96 to 0.98) and interrater reliability estimated at 0.98 (95%CI0.97to0.99). The absolute reliability of the Berg Balance Scale varies across the scale, with minimal detectable change with 95%confidencevaryingbetween 2.8/56 and 6.6/56

    6 weeks

  • 6 min walk test

    An increase in the distance walked indicates improvement in basic mobility. Resnik et al (2011) suggested in Amputee rehabilitation, Post training a difference of at least 45m should be observed for the 6 minute walk test to be sure that a "real" change in the patient's condition. The six-minute walk test is a simple cardiopulmonary functional testing modality. Its straightforward nature allows for a non-specific, integrated assessment of the many systems involved during physical activity. Specifically, its results can assist in ascertaining the degree of functional impairment and potentially lead to modifications in therapy for some cardiovascular and pulmonary conditions. This activity reviews the six-minute walking test, its physiological basis, uses in practice, and outlines the role of the healthcare team in its performance.

    6 weeks

Study Arms (2)

Lower Extremity HABIT-ILE GROUP A

EXPERIMENTAL

Hand Arm Bimanual intensive therapy including lower extremity (HABIT-ILE) is among the few neuro-rehabilitation treatments that specifically target UE and LE

Other: Lower Extremity HABIT-ILE GROUP A

group B Conventional treatment

ACTIVE COMPARATOR

Conventional physical therapy intervention The conventional physical therapy intervention included 5 minutes of range of motion, 10 minutes of stretching, 10 minutes of strengthening, and 5 minutes of muscle relaxation in each 30-minute session. Stretching tight muscles and strengthening weak muscles were the main focus of each session.

Other: group B Conventional treatment ( Conventional Treatment

Interventions

Hand Arm Bimanual intensive therapy including lower extremity (HABIT-ILE) is among the few neuro-rehabilitation treatments that specifically target UE and LE (19) This method uses concepts from motor skill learning in intensive training; it calls for postural control and continuous stimulation of UE and LE through various activities that are done continuously, progressively more difficult, for two hours every day for three weeks in group therapy (20) It is suggested that participants engage in structured tasks that gradually increase in motor complexity based on their development. Similarly, it involves postural and/or locomotor movements as well as functional tasks that call for the simultaneous use of both hands. (21) A variety of exercises that test the patient's ability to utilize their lower extremities to carry out daily duties are usually included in the rehabilitation program

Lower Extremity HABIT-ILE GROUP A

Conventional physical therapy intervention The conventional physical therapy intervention included 5 minutes of range of motion, 10 minutes of stretching, 10 minutes of strengthening, and 5 minutes of muscle relaxation in each 30-minute session. Stretching tight muscles and strengthening weak muscles were the main focus of each session.

group B Conventional treatment

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participants falling in the following category would be recruited into the study:
  • A hemiplegic patient due to unilateral stroke
  • Patients having sub-acute and chronic stroke
  • Stroke survivors between 40 and 60years old
  • Both genders
  • A hemiparetic patient with a chronic stroke (over 6 months of evolution)

You may not qualify if:

  • Participants falling in the following category would be excluded from the study:
  • Pregnancy
  • Major cognitive impairment interfering with the study (severe aphasia, psychiatric conditions)
  • Uncontrolled health issues (cardiac/renal failure)
  • Patients with depression who will be unable to cooperate during treatment
  • Patients who cannot perform the active movement of limb due to pre-stroke musculoskeletal problems
  • Cardiopulmonary diseases which could hinder their ability to participate in rehabilitation
  • Patients with any neuron disease and with lower-limb impairment caused by other neurological diseases
  • Visual and auditory abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

in helping hands institute of comprehensive therapy MANSEHRA

Mansehra, Kpk, 22020, Pakistan

RECRUITING

MeSH Terms

Conditions

StrokeIschemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain Ischemia

Study Officials

  • Mahat zafar, MS NMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

mahat Zafar, MS.Nmpt

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2026

First Posted

August 10, 2026

Study Start

July 30, 2026

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

August 10, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations