COMPARATIVE EFFECTS OF HAND ARM BIMANUAL INTENSIVE TRAINING (HABIT) AND PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION (PNF) PATTERNS ON UPPER EXTREMITY DYSFUNCTION IN PATIENTS WITH SUBACUTE STROKE
To compare the effects of Hand Arm Bimanual Intensive Training and Proprioception Neuromuscular Facilitation patterns on upper extremity dysfunction in patients with subacute strokes.
Design
Randomized Clinical Trial, single blind
Settings and conduct
Allied Hospital Faisalabad, Aziz Fatima Hospital Faisalabad and District Head Quarter Hospital Faisalabad.
Participants/Inclusion and exclusion criteria
Inclusion criteria includes Stroke patient clinically diagnosed or with scan of CT computed tomography or MRI magnetic resonance imaging, Sub-acute stroke patients, Age 35–60 years, Patient with GCS score >8 and vitally stable, On Mini-Mental State Exam score must be >24 and having no severe cognitive problems and Patients suffered from first time stroke and able to give informed consent.
Exclusion criteria includes Patients with severe cardiopulmonary complications, Any intracranial implant, Patient with pacemaker, Any kind of cranial defect, Patients with worsening condition that causes difficulties for physiotherapy treatment, All the medical conditions except stroke that limited the use of upper limb, Patients with epilepsy and Patients having previous history of stroke on same side that diminish upper extremity function.
Intervention groups
Group A will receive Hand Arm Bimanual Intensive Training (HABIT) and Group B will receive Proprioceptive Neuromuscular Facilitation (PNF) patterns
Main outcome variables
Spasticity, Motor function of upper extremity, Activities of Daily Living.
General information
Reason for update
Acronym
HABIT & PNF
IRCT registration information
IRCT registration number:IRCT20230526058301N1
Registration date:2023-09-11, 1402/06/20
Registration timing:registered_while_recruiting
Last update:2023-09-11, 1402/06/20
Update count:0
Registration date
2023-09-11, 1402/06/20
Registrant information
Name
Ayesha Affi
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 8868326
Email address
2021-ms-pt-066@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-24, 1402/05/02
Expected recruitment end date
2023-09-30, 1402/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
COMPARATIVE EFFECTS OF HAND ARM BIMANUAL INTENSIVE TRAINING (HABIT) AND PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION (PNF) PATTERNS ON UPPER EXTREMITY DYSFUNCTION IN PATIENTS WITH SUBACUTE STROKE
Public title
COMPARATIVE EFFECTS OF HAND ARM BIMANUAL INTENSIVE TRAINING (HABIT) AND PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION (PNF) PATTERNS ON UPPER EXTREMITY DYSFUNCTION IN PATIENTS WITH SUBACUTE STROKE
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Stroke patient clinically diagnosed or with scan of CT computed tomography or MRI magnetic resonance imaging
Sub-acute stroke patients
Age 35–60 years
Patient with GCS score >8 and vitally stable
On Mini-Mental State Exam score must be >24 and having no severe cognitive problems
Patients suffered from first time stroke and able to give informed consent
Exclusion criteria:
Patients with severe cardiopulmonary complications
Any intracranial implant
Patient with pacemaker
Any kind of cranial defect
Patients with worsening condition that causes difficulties for physiotherapy treatment
All the medical conditions except stroke that limited the use of upper limb
Patients with epilepsy
Patients having previous history of stroke on same side that diminish upper extremity function
Age
From 35 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
46
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by using Lottery method, in this method computerized generator will be used and patients will allocated into two groups according to numbers given to them.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will be single blind in the study. He/ She kept blind about his/her own treatment group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of The University of Faisalabad
Street address
West Canal Road, Faisalabad
City
Faisalabad
Postal code
37610
Approval date
2023-03-24, 1402/01/04
Ethics committee reference number
TUF/DR/SA/MSPP/2023/242
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
169.4
ICD-10 code description
Subacute stroke
Primary outcomes
1
Description
Spasticity
Timepoint
At baseline, after second week of intervention, after fourth week of intervention, after sixth week of intervention and after eight week of intervention
Method of measurement
Modified Ashworth Scale
Secondary outcomes
1
Description
Motor Function of upper limb
Timepoint
At baseline, after second week of intervention, after fourth week of intervention, after sixth week of intervention and after eight week of intervention
Method of measurement
Fugl-Meyer assessment scale for Upper Extremity
2
Description
Activities of daily living and motor function of upper limb
Timepoint
At baseline, after second week of intervention, after fourth week of intervention, after sixth week of intervention and after eight week of intervention
Method of measurement
Motor activity log-28 scores
Intervention groups
1
Description
Intervention group:
Category
Rehabilitation
2
Description
Intervention group:
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Allied Hospital
Full name of responsible person
Ayesha Affi
Street address
Jail Road adjacent to Faisalabad Medical University, Near Sargodha Road, Faisalabad.