To check the combined effect of Task Specific training and Roods approach in improvement of arm sensory and motor function in patients after stroke.
To check the combined effect of Task Specific training and Roods approach in improvement of arm spasticity in patients after stroke
Design
Community based, parallel group, single blind, randomized controlled trial.
Settings and conduct
Settings of the trial are Allied hospital Faisalabad and DHQ hospital Faisalabad. Participants will be blind in the study because treatment will be provided individually and alone. Participants will not know which group they belong to because treatment will be performed by the therapist and will not be explained in detail to the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Age between 45-65 years.
• Acute <6 months upper extremity paresis after stroke.
• Muscle power 0-3 muscle grade of all muscle of upper limb by MMT according to oxford scale
• Time since stroke < 6months.
• Sufficient cognitive ability to participate.
• Both genders
• Before stroke they were able to wash their hands and feed themselves.
• Had no premorbid severe arm condition before stroke
Exclusion criteria:
• Uncontrolled Hypertension.
• Severe dysphasia.
• Occipital/ cerebellar lesion.
• Other neurological, neuromuscular or orthopedic lesion.
• Severe comorbidity.
• Concurrent participation in other upper extremity stroke treatment
• Perceptual, apraxic or major cognitive defects.
• Arm contracture
• Severe arm dysfunction before stroke
Intervention groups
Group A will receive common treatment and Rood’s treatment approach.
Group B will be subjected to task specific training along with common treatment.
Group C will receive combination of both Rood’s approach and Task specific training along with common treatment.
Main outcome variables
Motor and sensory function of arm
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210814052177N1
Registration date:2021-09-16, 1400/06/25
Registration timing:retrospective
Last update:2021-09-16, 1400/06/25
Update count:0
Registration date
2021-09-16, 1400/06/25
Registrant information
Name
Maham Saleem
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 41 2644442
Email address
dpt-fa14-037@tuf.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-26, 1400/03/05
Expected recruitment end date
2021-08-28, 1400/06/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Combined effect of Task specific training and Rood’s approach to improve motor and sensory arm function in patients with stroke.
Public title
Effect of task specific training & Rood’s approach on stroke patients.
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 45-65
Acute <6 months upper extremity paresis after stroke.
Muscle power 0-3 muscle grade of all muscle of upper limb by MMT according to oxford scale
Time since stroke < 6months.
Sufficient cognitive ability to participate
Both genders
Before stroke they were able to wash their hands and feed themselves.
Had no premorbid severe arm condition before stroke
Exclusion criteria:
Uncontrolled Hypertension.
Severe dysphasia
Occipital/ cerebellar lesion
Other neurological, neuromuscular or orthopedic lesion.
Concurrent participation in other upper extremity stroke treatment
Perceptual, apraxic or major cognitive defects.
Arm contracture
Severe comorbidity.
Age
From 45 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Non probability purposive sampling technique will be done on the patients on individual basis. Simple randomization will be done and patients will be allocated to three different groups by lottery method with sealed envelopes and identical slips of paper.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will be blind in the study because treatment will be provided individually and alone. Participants will not know which group they belong to because treatment will be performed by the therapist and will not be explained in detail to the patients. Both techniques will be performed manually and patient will be unaware of the treatment techniques. As both are manual techniques performance of these intervention will be made similar to patients.
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
P720 neelam street green view colony Faisalabad
City
Faisalabad
Postal code
38000
Approval date
2021-05-25, 1400/03/04
Ethics committee reference number
TUF/DR/MSPP/305
Health conditions studied
1
Description of health condition studied
Sensory and motor function of arm in Stroke patients
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
Sensory function of arm
Timepoint
Before intervention and after six week of intervention.
Method of measurement
Fugl meyer assessment scale
2
Description
Motor function of arm
Timepoint
Before intervention and after six week of intervention.
Method of measurement
Fugl meyer assessment scale
Secondary outcomes
1
Description
Spasticity of arm muscle.
Timepoint
Before intervention and after six week of intervention
Method of measurement
Modified ashworth scale
Intervention groups
1
Description
Intervention group: Intervention group 1 will receive common treatment and Rood’s treatment approach for three times a week on alternate days, for six weeks. Rood's approach include: Tapping (over the arm muscle to be facilitated,3-5 times per repetition, 10 repetitions per day, 3days/ week) • Icing (3-5 sec/ repetition, 10 repetitions/day, 3days/week).• Fast brushing (Apply for 3 to 5seconds & repeated after 30 sec, 10 repetitions/day).• Light touch (3-5 strokes/repetition, 30 sec rest period between strokes, 10 repetitions/day).• Heavy joint compression (Joint Compression >body wt. applied through the longitudinal axis of the bone.)
Category
Rehabilitation
2
Description
Intervention group: Intervention group 2 will be subjected to task specific training along with common treatment for 45 minutes, three times a week for six weeks. Task specific training involve 20-30 trials of each activity. Touch a wall at shoulder level• Touch his cheeks and hair• Slide a ball with extensor effect of forearm• Reach activities• Reaching out toward a jar• Driving the wrist/finger extensors to open the paretic hand.• Grabbing the jar• Grasp a ball
Category
Rehabilitation
3
Description
Intervention group: Intervention group 3 will receive combination of both Rood’s approach and Task specific training along with common treatment. Rood's approach include: Tapping (over the arm muscle to be facilitated,3-5 times per repetition, 10 repetitions per day, 3days/ week) • Icing (3-5 sec/ repetition, 10 repetitions/day, 3days/week).• Fast brushing (Apply for 3 to 5seconds & repeated after 30 sec, 10 repetitions/day).• Light touch (3-5 strokes/repetition, 30 sec rest period between strokes, 10 repetitions/day).• Heavy joint compression (Joint Compression >body wt. applied through the longitudinal axis of the bone). Task specific training involve 20-30 trials of each activity. Touch a wall at shoulder level• Touch his cheeks and hair• Slide a ball with extensor effect of forearm• Reach activities• Reaching out toward a jar• Driving the wrist/finger extensors to open the paretic hand.• Grabbing the jar• Grasp a ball