Effects of Neurodevelopmental Technique Versus Mirror Therapy on Coordination, Functions and Ambulation in Sub-acute Hemiplegic Stroke Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Ambulation
Study Overview
Brief Summary
As neurodevelopmental technique and mirror therapy had different effects on lower limb coordination, functions and ambulation. Both had proven to be helpful in the stroke patients to gain functional independency. Therefore, there was need to find out the best treatment approach either NDT, mirror therapy or both are equally effective to improve motor functions, coordination and ambulation of lower limb. This study would provide the health professionals the evidence to use best technique among these according to improvement in patients' coordination, function and ambulation.The study will be randomized clinical trial. This study will be conducted at the University of Lahore. A sample size of 40 will be randomly allocated by into two experimentals groups, (20 participants in each group), by the lottery method. All the screened and willing participants will be randomly allocated to two groups (Group A: Experimental group Neurodevelopmental technique, Group B: Experimental Group mirror therapy exercise) by lottery method. This study will be a single blinded study in which assessor will be blinded.
Detailed Description
The Neurodevelopmental Technique (NDT), also known as the Bobath concept, is a hands-on treatment approach focusing on normalizing movement patterns and reducing muscle tone abnormalities through guided and facilitated movement. It emphasizes postural control, alignment, and symmetrical movement to enhance motor recovery. Bobath approach works on the different types of movement dysfunctions and is based on the active involvement of the patients so that they can develop motor control. Manual handling is holding the patient at specific proprioceptive points, for example, joint compression and distraction, so that patients can respond actively to perform functions. Manual handling can be of different types and is slowly removed to make the patient independent in motor activities. This type of therapy incorporates improved functional control and independence. Mirror Therapy (MT), on the other hand, involves using a mirror to create a visual illusion of movement in the affected limb by reflecting the movements of the unaffected limb. This approach stimulates the brain's motor cortex and supports cortical reorganization through visual feedback, which may facilitate motor recovery and improve function Screening: Participants, will be referred by the Neuro Physician or Medicine Specialist of University of Lahore Teaching Hospital will be assessed for the eligibility criteria. Patients fulfilled the eligibility criteria will be asked to sign the consent forms before entering them to the study.
Recruitment: All the participants who will meet the criteria and sign the consent form will be recruited into the study.
Randomization and Allocation: All the screened and willing participants will be randomly allocated to two groups (Group A: Experimental group Neurodevelopmental technique, Group B: Experimental Group mirror therapy exercise) by lottery method.
Blinding: This study will be a single blinded study in which assessor will be blinded.
Intervention Routine Physical Therapy The treatment will start by routine physiotherapy (RPT) comprised of stretching and ROM in both experimental groups. In ROM following exercises including; hip (flexion, extension, abduction and adduction), knee (flexion, extension), ankle (plantarflexion, dorsiflexion, inversion, eversion and circumduction) and toe (flexion & extension). Stretching exercises included heel cord, gastrocnemius and hamstring stretch. Each ROM exercises were repeated 10 times with rest gap of 1 minute. Stretching exercises will repeated 5 times in one session and stretch will be held for 10 seconds. Time for RPT will be 20-25 minutes including rest intervals.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Single (Outcomes Assessor) Study will be single and assessor blinded. Participants will be masked about other groups but they will know what treatment they will be receiving or what exercises they will be doing. Principal investigator would also not be masked or blinded because investigator would be applying the techniques on participants of both group. So participant and and principal investigator cannot be blinded. Only assessor will be blinded and he will take outcome measures without knowing the problem and treatment techniques.
Eligibility Criteria
- Ages
- 45 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age range between 45 to 65 years
- •Both genders
- •Sub-acute stroke hemiplegic cases; clinically stable, fully oriented and conscious.
- •Both ischemic and hemorrhagic patients were be included.
- •Patients with mini mental status examination (MMSE) (score > 23)
Exclusion Criteria
- •Patients had recurrent stroke.
- •Any systemic conditions that limit functions such as; cardiac diseases (exertional dyspnea, angina, Myocardial Infarction, Pacemaker) Pulmonary diseases (Asthma, Pulmonary Fibrosis etc.), Diabatic neuropathy, Diabetic foot, Varicose veins etc
- •Other neurological conditions, such as; foot drop, muscular dystrophy, Myasthenia Gravis, Parkinsonism
- •Any visual and hearing problem
- •Any surgical and traumatic history of fractures, dislocations and/or brain injury due to any traumatic events.
Outcomes
Primary Outcomes
Ambulation
Time Frame: Baseline and Week 12
Ambulation will be assessed using the Six-Minute Walk Test (6MWT), which measures the distance a participant walks on a flat surface in six minutes. Unit of Measure:- Meters
Lower Extremity Motor Function
Time Frame: Baseline and Week 12
Lower extremity motor function will be assessed using the Fugl-Meyer Assessment-Lower Extremity (FMA-LE). Unit of Measure:- Total score (0-34)
Lower Limb Coordination
Time Frame: Baseline and Week 12
Lower limb coordination will be assessed using the Lower Extremity Motor Coordination Test (LEMOCOT). Unit of Measure:- Number of target touches completed in 20 seconds
Secondary Outcomes
No secondary outcomes reported
