RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
KARNATAKA, BANGALORE
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
1. / NAME OF THE CANDIDATE AND ADDRESS / Mr.VELAYUTHAM SELVA GANAPATHYNo.24, 1 cross, someshwar nagar,
Jay nagar 1 block, Bangalore-11
2. / NAME OF THE INSTITUTION / The Oxford college of Physiotherapy
J. P. Nagar, 1st Phase
BANGALORE-78
3. / COURSE OF THE STUDY AND SUBJECT / Master of Physiotherapy
Neurology and Psychosomatic disorders
4. / DATE OF ADMISSION TO THE COURSE / 12.06.2007
5. / TITLE OF THE STUDY
“THE EFFECTS OF COMMUNITY AMBULATION TRAINING ON AMBULATORY STATUS AND QUALITY OF LIFE IN CHRONIC STROKE”
6.
7.
8. / BRIEF RESUME OF THE INTENDED WORK
6.1a. Introduction
Stroke is one of the foremost causes of morbidity and mortality and poses a major socioeconomic problem in young patients especially in developing countries1. Stroke is a leading cause of disability causing a variety of impairments that compromise quality of life.
The WHO defines stroke as a focal neurological impairment of sudden onset and lasting more than 24 hrs and of presumed vascular origin2. In India the incidence of cerebro vascular diseases is 36/100000 (age adjusted annual incidence rate is 105/100000) and prevalence of stroke is 147/100000(age adjusted prevalence 334/100000) 3.
Stroke causes variety of clinical deficits, which includes level of consciousness, and impairment of sensory, motor, and cognitive perceptual, and language function. Motor deficits are characterized by paralysis (Hemiplegia) or weakness (Hemiparesis) typically on the side of the body opposite to the lesion4.
Hemiplegia following stroke reduces the patient’s ability to walk, as a result, the person is become dependent in moving about the home and community. The goal of rehabilitation is to restore optimal physical function and psycho social-vocational restoration to enable the patient to become a productive participant in the community5. Stroke rehabilitation program aims at gait training and thereby increase the patient’s ability to perform the action in situation where it is needed. At present gait training program majorly focuses on Posture correction, symmetry, balance, Stretching exercise for the tight muscles, part practice of components of gait6, parallel bar walking and treadmill gait training7.
6.1b Need of the study
In spite of this intensive gait-training program the patients are incapable of returning back to the premorbidity roles in the society as their ambulation is restricted in the community8. Community ambulation is defined as an independent mobility outside home which includes the ability to confidently negotiate uneven terrain, private venues, shopping centers and other public venues9 .
A study by Lord SE10 found that nearly one third of stroke patients were not able to come out of their house independenly. Another study by Keith hill11 support the above statement in that he found out only 7% stroke patients were able to meet the criteria for an independent community ambulation. These study results show that residual mobility problems exist in post rehab stroke patients particularly with respect to community ambulation. The Restricted community ambulation causes a social handicap situation12 as stroke victims are not able to participate in social, leisure activities13, return back to work14 and living with overall reduced Quality of life satisfaction15.
The environment where the stroke patient lives in the community plays a major role in creating handicap situation16 as it pose’s a very challenging task in terms of time constrains, terrain characters, ambient conditions, physical load, attentional demands, postural transitions and traffic17,18. Although Patients might have learned to walk in a closed environment like a treatment area but the transfer of learning from one situation (clinical environment) to another situation (community environment) does not happen automatically. Our training program should be modified19, 11,13 in order to focus on walking training in an environment which pose’s various challenges that prepares the patient for the real world. A study by Lord SE suggest that people with chronic stroke cope well with the challenges of varied environment 20 .
The recent approaches have started to incorporate transfer of clinical training in to daily life skills as one of the major steps in training in the form of task oriented goals21 Carr &shepherd) . Studies have analyzed the effect of Dual task training (Attention demand)22 obstacle crossing23 and stepping over an obstacles24 (terrain characters) on improving gait performance. However none of these studies were conducted in a community environment and not considered more than one environmental dimension as it is identified in earlier studies conducted by Shumway cook & patla18.
Hence in the light of the above deficiencies, there is a need for a clinical trial analyzing the beneficial effect of community ambulation training on mobility status and overall quality of life of patients with chronic stroke. The aim of the study is intended to find whether community ambulation training can improve mobility status and thereby bring about better quality of life in stroke subjects.
6.2 REVIEW OF LITERATURE
Community ambulation
1. Susan E Lord and colleagues (2004,2005)9,10has given the definition, importance and discussed the various measures available for community ambulation and suggest that it’s meaningful out come after stroke.2. Patla and shumwaycook (2002)18 Given an operational definition for community ambulation that considers various environmental dimensions.
3. Keith Hill (1997)11 Insists about the importance of community ambulation training.
4. Arlene Scmid (2007)25 Discussed about the measurement of ambulation in stroke.
5. Perry .J (1995)8mention about the classification of walking handicap and Suggest that
measurement of therapeutic out come in relation to social advantage will be beneficial.
Environmental factors affecting community ambulation
1. Rochette A, Desrosiers J, Noreau L (2001)16 state that perceived barriers in the physical and social environment contribute the handicap creation process following stroke.
2. Patla and shumway –cook (2002)18 Identified about various environmental dimensions
can affect community ambulation .
2. Stanko E et al1 (2001)17Discussed about the mobility inside home, outside home, in the
community of stroke patients and pointed out major problem areas.
4. Lord SE, Rochester L, Weatherall M (2006)20Suggest that Chronic stroke patient can
cope Well with the challenges of varied environment and gait automacity may be achieved
over a Time to a functional level.
5. Corrigan r, Mcburney H. (2007)19said that an individual participation in the society is is a
result of interaction between personal character and environment.
Recent approaches in gait training
1. Katherine J.Sullivan (2006)26found that meaningful changes in walking achieved in a task
Specific training of stroke patients.
2. Yang YR (2007)22found that dual task bases exercise is feasible and beneficial for improving walking ability in subjects with chronic stroke.
Reliability and Validity of scales used
1. Linda S Williams & co-workers (1999)28 found the internal reliability of the domains of the Stroke Specific Quality of Life Scale (SS-QOL) questionnaire remained quite high, with a scores ≥0.73 in all domains.
2. Howe,J., Inness, E &co workers (2006)29Found that Community balance and mobility
Scale is sensitive, valid and reliable. (>0.90)
3. Myers AM, Fletcher PC,Myers AN ,shrek W (1998)30Found that Activities specific
Balance confidence scale is valid and reliable.
4. Perry.j (1995) 8discussed about the walking ability questionnaire.
6.3 OBJECTIVES OF THE STUDY
· To evaluate the effectiveness of community ambulation training on changes in mobility Status in stroke subjects.
· To assess the effect of community ambulation training on capacity, performance, confidence and quality of life in subjects with stroke.
6.4 HYPOTHESIS
Research hypothesis:
There is a significant influence of community ambulation training on mobility status and
quality of life among the persons with chronic stroke.
Null hypothesis:
There is no significant influence of community ambulation training on mobility status and
quality of life among the persons with chronic stroke.
6.5 VARIABLES
· Dependent variable: Ambulatory status, Balance confidence level, Quality of life.
· Independent variables: Community ambulation training
· Extraneous variables: Conventional gait training
MATERIALS AND METHODS
7.1 STUDY DESIGN AND SETTING
7.1.1 STUDY DESIGN
A Randomized controlled study to find out the effect of community ambulation training in
persons with chronic stroke
7.1.2 SOURCE OF DATA
Samples for the study will be collected from:
· Agadi Centre for Physical Medicine And Neurorehabilitation, Bangalore.
· NIMHANS, Bangalore.
· The Oxford Rehabilitation centre, Bangalore
· Jayanagar General Hospital, Bangalore
7.2 METHODOLOGY
7.2.1 POPULATION
Both male and female patients with chronic stroke.
7.2.2 SELECTION CREITERIA
1. Inclusion criteria
a. Patients with chronic stroke of more than 6 months to 3 years duration living in the community
b. Ambulant for at least 5 meters
c. Age of 25 to 65
d. MMSE Score 24 and above
e. Patients who shows interest and willing to participate community ambulation
2. Exclusion criteria
a. Patients suffering from the following conditions.
· Heart diseases
· Diseases of the respiratory system
· Severe osteoarthritis of knee and hip joints
· Fracture of bones of lower limb
b. Any progressive or non progressive neurological diseases other than stroke, which can limit
the functional activities.
c. Uncooperative patient
d. Subjects having aphasia.
7.2.3 SAMPLING METHOD AND SAMPLE SIZE
a. Sampling method: simple random sampling using random number method .
b. Sample size: 30 stroke patients.
7.2.4 PROCEDURE
The purpose of the study will be explained to all the subjects and his caretaker in the subject’s own languages. The entire subject will be assessed with specific Performa. The subject will be selected based on the inclusion and exclusion criteria Thirty subjects will be selected for the study and they will be randomly divided in to two groups i, e (A) Control and (B) Experimental .The pre,post training and one month follow up performance of both group will be assessed with a set of Assessment scales which includes 1.Community balance and mobility scale (Capacity level) 2.Activity specific balance confidence scale (Confidence level) 3.Walking ability questionnaire(Performance level)4.Stroke specific quality of life(overall Quality of Life).
Task
Control group (A)
Here the subjects will receive conventional training in a clinical set up which might include range motion exercise, Spasticity reliving techniques, Inhibitory and facilitatory technique, Posture correction, walking in the parallel bar. Additional gait training inside the clinic with a minimum of 60 meters of walking.
Experimental group (B)
In this the subjects undergo community ambulation training in addition to conventional training. The training will be given in individual’s community environment which is of relatively less traffic, for a fixed distance of 10 meters with 5 different environmental constrains which include
1.Temporal factors, 2.Ambient conditions 3. Attention demands, 4. Terrain characters, 5.physical
load. Overall 6 trails will be given to do this task (Table 1) Through out the training phases the
therapist and one caregiver will shadow the subject in order to ensure his/her safety.
1.Temporal factors: The subject will walk at three different speeds.i, e slow, self-selected and fast speeds.
2.Ambient conditions: The subject will walk in a brighter environment first and then a darker environment by wearing a darker spectacle.
3.Attention demands: The subjects will be asked to talk while walking by answering the questions asked by the therapist.
4.Terrain Characters: An obstacle of two different height and length will be placed in path. The subject will be asked to cross the obstacle and walk.
5.Physical load: The subject will be asked to lift and carry 1 kg fruit bag/basket with the unaffected arm and walk .
The training program schedule as follows
Trial
/ Temporal Factor / Ambient Condition / Attentional Demand / Terrain Character / Physical load1 / Slow / Light / Talk / Obstacle / Carry weight
2 / Slow / Dark / Talk / Obstacle / Carry weight
3 / Self selected / Light / Talk / Obstacle / Carry weight
4 / Self selected / Dark / Talk / Obstacle / Carry weight
5 / Fast / Light / Talk / Obstacle / Carry weight
6 / Fast / Dark / Talk / Obstacle / Carry weight
During each trial the subject will walk for 10 meters and hence a total of 60 meters.
Duration of the study:-
The community ambulation training for a experimental group will be around 45 minutes. The
conventional gait training for both the group will be around 45 minutes. The treatment will be given
for a total duration of two weeks with a frequency of 6 times per week. At the end of two weeks, the patient will be reassessed using outcome scales mentioned before. An additional follow up measure on the outcome variable will be done after a period of 1 month for finding out the carry over effects.
MATERIALS REQUIRED
· Stop watch,
· Measurement tape
· Adult and pediatric size shoe box Shoe box of various height,(41/2x12x6),(2x6x3)-in inches
· A fruit basket of 1 kg weight
· A dark goggle
7.3. OUTCOME MEASURES AND STATISTICAL ANALYSIS
7.3.1 OUTCOME MEASURES
· Activities specific balance confidence scale,
· Community balance and mobility scale,
· Walking ability questionnaire,
· Stroke specific quality of life scale.
(Details attached in annexure IV)
7.3.2 STATISTICAL ANALYSIS
a. DATA MANAGEMENT
Pre and post score obtained from the outcome scales of both control and experimental group are arranged in two groups. These score indicates their level of mobility status and overall quality of life. An additional post training score of both the groups will be collected and grouped in order to analyse the carry over effect.
b. DATA ANALYSIS
Signed rank test will be used as a stastical tool to analyse pre and post score of individual group and comparison between two group will be done by Rank Sum Test27.
7.4a. Does the study require any interventions to be conducted on patients or other humans or animals?
Yes. The study requires checking the effectiveness of walking training in a less traffic community environment in improving Ambulatory status on subjects with stroke.
7.4b. Has the ethical consent for the study has been obtained from the institution in case ?
Yes, it has been obtained from the institution. Ethical clearance form is attached as appendix I. An informed consent will be obtained prior to study from each subject in their native language (appendix II).
REFERENCES:
1. Mehndiratta M, Aggerwal P stroke in young adults, study from a university hospital in north