Stroke (CVA) or Transient Ischemic AttackNCT07754110
Effect of HABIT-ILE on Balance and Coordination Among Stroke Patients
A study testing Lower Extremity HABIT-ILE GROUP A and group B Conventional treatment ( Conventional Treatment in people with Stroke (CVA) or Transient Ischemic Attack, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke (CVA) or Transient Ischemic Attack
- What is being tested?
- Lower Extremity HABIT-ILE GROUP A and group B Conventional treatment ( Conventional Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Jul 2026to 1 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
in helping hands institute of comprehensive therapy MANSEHRA
Mansehra, Kpk, 22020
Laiba Sarfraz, MS NMPT, 03114780808, laibasarfraz504@gmail.com
sarfraz
About this study
Official title: Effect of HABIT-ILE ( Hand Arm Bimanual Intensive Training Including Lower Limb Extremity ) on Balance and Coordination Among Stroke Patients
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
Read the detailed description
Stroke often causes weakness, impaired coordination, and poor balance, leading to difficulties in performing daily activities independently. HABIT-ILE (Hand-Arm Bimanual Intensive Therapy Including Lower Extremity) is a task-oriented rehabilitation approach that focuses on intensive, repetitive practice of coordinated movements involving both upper limbs and lower extremities. It aims to improve motor control, balance, gait, and functional independence by encouraging the use of the affected side during meaningful activities.
The purpose of this topic is to evaluate the effectiveness of HABIT-ILE in improving balance and coordination among stroke patients. By enhancing bilateral limb function and postural control, this therapy may help patients regain mobility, reduce the risk of falls, and improve their overall quality of life. The findings may provide evidence for incorporating HABIT-ILE into stroke rehabilitation programs to achieve better functional outcomes.
- Being tested
- Lower Extremity HABIT-ILE GROUP A, group B Conventional treatment ( Conventional Treatment
- Medical subject headings
- Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower Extremity HABIT-ILE GROUP AOther
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
group B Conventional treatment ( Conventional TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: group B Conventional treatment ( Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start30 Jul 2026
- Primary completion30 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke (CVA) or Transient Ischemic AttackStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mahat zafar, MS NMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754110
- Sponsor's protocol ID
- Laiba Sarfraz
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No