Neuro-rehabilitation for improving Hand function in patients with Stroke

Not yet recruiting

Conditions: Middle cerebral artery syndrome,

Registration Number: CTRI/2024/07/070496

Brief Summary: Stroke patients who met the inclusion and exclusion criteria will be selected for the study and will then be asked to sign a consent form. After signing the informed consent, stroke patients will be assigned to experimental and control group. Baseline measurement including Mini mental state examination (MMSE), demographic data etc. will be done to allow for more in-depth description of the participantâ€™s impairment. The experimental group will receive the developed intervention and control group will receive conventional physiotherapy. All outcome measures will be recorded at the baseline assessment, and after every two week of intervention and at the end on completion of intervention.

Randomization will be performed using computer generated randomization table with a 1:1 ratio by a statistician not involved in the study. Subjects will be blinded to the groups will be allocated to Neuro-rehabilitation strategies group (Experimental Group) and conventional intervention group (Control Group). Group allocations will be assigned through sealed opaque envelopes. The envelopes will be kept in a closet by independent researcher who are not involved in the study.

Experimental group will receive developed neurorehabilitation strategies and conventional physiotherapy that will be given to control group includes range of motion, stretching and strengthening exercises of upper limb.

The duration of the study will be 12 weeks as most of the improvement in hand function occurs in between 8 weeks to 32 week. The dosage will be 45 mins, 5 days per week, at 50-80 % of maximum Heart Rate. This 45 mins session will include 5-10 min of warm-up and cool-down.

Outcome measures will be evaluated at baseline, 6th and at the end of 12th week of intervention

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Patients with acute episode of stroke 2.
Patient with Middle Cerebral Artery (MCA) involvement 3.
Patients having haemorrhagic or non-haemorrhagic stroke 4.
Patients who were in stage III in Brunnstrom hand recovery scale.
Mini mental State Examination Scale (MMSE) Score equal to or greater than 24 6.

Exclusion Criteria

Patients having a history of prior stroke involving other hemisphere 2.
Patients having poor cognitive function and aphasia 3.
Patients having visual ,hearing deficit and perceptual deficit 4.
Patients having emotional changes such as emotional lability, indifference, euphoria, anosoagnosia 5.
Patients having secondary deformation due to musculoskeletal disease in hand 6.
Patient having musculoskeletal disorder affecting shoulder.
Pain with VAS score greater than 4 8.
Patients having uncontrolled diabetes and hypertension.
Patient having any other neurological disorder except stroke Demyelinating and Degenerative diseases of brain such as myelopathy ,myopathy, traumatic head injury, intracranial tumour 10.
Arthritis 11.
Acute Respiratory Distress Syndrome 12.
Patient with Myocardial Infaction ,stable angina 13.
Patient having pacemaker or any other metal implant in body 14.
Pregnancy 15.
Uncontrolled epilepsy 16.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spasticity,Cognitive status,Grip strength,Pinch strength,Hand function,Co-activation, muscle activation,Disability,Fine motor skills,Finger dexterity	Outcome measures will be evaluated at baseline, 6th and at the end of 12th week of intervention

Secondary Outcome Measures

Name	Time	Method
Stroke Motor Recovery Scale,Disability,Recovery of Motor Impairment,Disability,Lifestyle after stroke	Outcome measures will be evaluated at baseline, 6th and at the end of 12th week of intervention

Trial Locations

Locations (1): Jamia Hamdard
🇮🇳
South, DELHI, India
Jamia Hamdard
🇮🇳South, DELHI, India
Dr Sunil Kohli
Principal investigator
9873351206
sunil.kohli@gmail.com
Prachi Tiwari
Principal investigator
9811644726
prachitiwari005@gmail.com