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- Ensaio Clínico NCT07578948
Comparative Effects of Task Oriented Progressive Resistance Training and Modified Otago Exercise Among Stroke Patients.
Comparative Effects of Task Oriented Progressive Resistance Training and Modified Otago Exercise on Balance and Lower Limb Motor Function Among Stroke Patients.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Stroke is a clinical syndrome marked by the sudden onset of localized neurological indications that persist longer than 24 hours or result in death. This definition includes stroke both due to infarction and due to hemorrhage. Stroke is the second or third most common cause of death, one of the main causes of adult disability worldwide, and a global health problem. The remaining 80% are due to ischemic stroke which itself has a number of different subtypes, including large artery disease, cardio embolism, and small vessel disease. This study aims to evaluate the effects of Task Related Progressive Resistance Training and Modified Otago Exercises on balance and lower limb motor function in stroke patients.
A randomized controlled trial will be conducted over eleven months. Fifty-two stroke patients aged 45 to 65 years will be selected using non-probability convenient sampling technique. Participants will be randomly allocated into two groups using a lottery method. Group A will receive Task-Oriented Progressive Resistance Training which includes functional strengthening activities targeting lower limb muscles, while Group B will undergo Modified Otago Exercise Program which involves balance and strength exercises used to prevent fall in stroke. Interventions will be carried out over eight weeks, with assessments conducted pre- and post-intervention using the Berg Balance Scale (for balance), Fugl-Meyer Assessment (for lower limb motor function) and Mini Mental State Examination (for cognitive function). Data will be analysed using SPSS version 26, applying parametric or non-parametric tests based on data normality.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Punjab Province
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Lahore, Punjab Province, Paquistão, 54000
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Adults aged 45 to 65 years. (9)
- Both genders male and female.
- Clinically diagnosed with ischemic stroke.
- Chronic stroke patients 6 to 10 months.
- Presence of hemiparesis with mild to moderate motor deficits FMA-LE score 34.
- Cognitive impairment MMSE score more than 26.
- Ability to walk at least 10 meters with or without an assistive device
Exclusion Criteria:
- Dementia or major neurocognitive disorder. (6)
- Complete paralysis or unable to participate in active exercise. (11)
- Patients with severe joint pain or arthritis are excluded due to reduce risk of injury and avoid confounding factors.
- Recent fractures, or other musculoskeletal issues limiting exercise participation.
- Suffering from physical diseases that prevent full participation in training.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Modified otago exercises
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Warm up Head, neck, back extension, trunk, and ankle movement
Outros nomes:
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Comparador Ativo: Task oriented progressive resistance training
Participants receive interventions 3 session per week for 4 weeks
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Standing and reaching in different directions for objects beyond arm's length
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Fugl-Meyer Assessment (FMA)
Prazo: baseline to 4rth week
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Fugl-Meyer Assessment of Lower Extremity (FMA-LE) total score interpretation ranges from 0 to 34, with higher scores indicating better motor function.
Generally, a score of 34 represents normal function, while scores below 29 indicate varying degrees of disability.
(15) All FMA-LE forms and subscales showed a high internal consistency (Cronbach's alpha>0.91).
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baseline to 4rth week
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Berg Balance Scale (BBS)
Prazo: Baseline to 4rth week
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The BBS is postural balance scale containing 14 items including standing and sitting unsupported, reaching forward, and placing the alternating foot on a stool.
Administering the BBS takes approximately 15 min.
Each of the 14 items are scored on a 5-level ordinal scale from 0 (-unable to perform or requiring help‖) to 4 (-normal performance‖), thus providing a potential maximum score of 56 points.
(13) test-retest (ICC = 0.96; 95% CI, 0.93-0.98)
and inter-rater (ICC = 0.93; 95% CI, 0.87-0.97)
reliability was excellent
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Baseline to 4rth week
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Mini Mentel Scale (MMS)
Prazo: baseline to 4rth week
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The Mini-Mental State Examination (MMSE) is a brief test used to screen for cognitive impairment, particularly in older adults.
It assesses different aspects of cognitive function, including orientation, attention, memory, and language.
The MMSE is scored on a scale of 0-30, with a score of 24 or higher generally considered normal.
(17) The Mini-Mental State Examination (MMSE) generally demonstrates good internal consistency reliability, as indicated by Cronbach's alpha values ranging from 0.78 to 0.81.
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baseline to 4rth week
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sabiha Arshad, MS, Riphah International University
Publicações e links úteis
Publicações Gerais
- Murphy SJ, Werring DJ. Stroke: causes and clinical features. Medicine (Abingdon). 2020 Sep;48(9):561-566. doi: 10.1016/j.mpmed.2020.06.002. Epub 2020 Aug 6.
- Cekmece C, Sade I, Ozcan E, Balci S. Investigation of the effect of task-oriented occupational therapy on daily living activity performance in chronic stroke patients. Pak J Med Sci. 2024 Jul;40(6):1214-1218. doi: 10.12669/pjms.40.6.7954.
- Appelros P, Stegmayr B, Terent A. Sex differences in stroke epidemiology: a systematic review. Stroke. 2009 Apr;40(4):1082-90. doi: 10.1161/STROKEAHA.108.540781. Epub 2009 Feb 10.
Datas de registro do estudo
Datas Principais do Estudo
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Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
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Última atualização enviada que atendeu aos critérios de controle de qualidade
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Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- REC/RCR&AHS/25/0214
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