- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07576166
Combined Effects of Rhythmic Breathing and Balance Training on Balance and Trunk Control in Stroke Patients
Combined Effects of Rhythmic Breathing Exercises and Balance Training on Balance and Trunk Control in Patients With Stroke
The goal of this study is to evaluate the combined effects of rhythmic breathing and balance training on balance, trunk control and postural control in patients with sub-acute stroke. The main questions it aims to answer are:
- Will there be a difference in combined effects of rhythmic breathing exercises and balance training on balance and trunk control in patients with stroke?
- Will there be no difference in combined effects of rhythmic breathing exercises and balance training on balance and trunk control in patients with stroke? The participants will be evenly divided into two groups,
- the experimental group will receive rhythmic breathing exercises along with balance training and conventional physical therapy
- the control group will only receive balance training and physical therapy. Both the groups will perform their respective exercises for 60 minutes, 3 days a week for consecutive 8 weeks.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Imran Amjad, Phd
- Número de telefone: 033324390125
- E-mail: imran.amjad@riphah.edu.pk
Locais de estudo
-
-
Punjab Province
-
Sargodha, Punjab Province, Paquistão, 40100
- Recrutamento
- Dr. Faisal Masood Teaching Hospital Sargodha
-
Contato:
- Hira Jabeen
-
Investigador principal:
- Anam Maqbool, MS-PT
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Age 45-65 years old
- Either gender
- Sub-acute stroke (3-6months)
- The cognition level of patient according to Mini Mental Score Examination will be >24
- The trunk control of patient based on Trunk Impairment score is 20 or less than 23
- First-ever ischemic stroke
- Ability to tolerate at least 60 min exercise according to berg scale scoring less than 8
- Agree to sign the written informed consents
Exclusion Criteria:
• Severe visual hemianopsia
- Acute diseases of the heart, brain, kidney and other organs
- Sensory neuropathy such as diabetic neuropathy
- Balance dysfunction due to other neurological disorders
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Rhythmic breathing exercises
|
The protocol for Rhythmic Breathing Exercises (22) is given as: Position: Supine with knees and hips slightly flexed, in a comfortable position Inhalation Phase: Deep inhalation with conscious outward movement of the abdomen; pause and hold for 10 seconds Exhalation Phase: Slow exhalation with conscious abdominal retraction, maintaining a slow and deep rhythm Hand Placement: One hand on the chest, one on the abdomen to monitor movement Breathing Cue: Only the hand on the abdomen should move during breathing; the chest should remain still Repetitions: 3 sets of 10 repetitions Rest Between Sets: 1 minute Total Duration: Limited to 10 minutes
Outros nomes:
Sitting-to-Standing: Performed using a stool with 3 sets of 5 repetitions Lateral Stepping: Walk 3 meters back and forth sideways with 3 sets of 5 repetitions Forward and Backward Stepping: 5 times with right leg stepping first, 5 times with left leg stepping first with 3 sets of 5 repetitions Forward Walking: Walk 3 meters back and forth, turn right at one end and left at the other wit 3 sets of 5 repetitions Stepping Up and Down: 5 times with right leg stepping first, 5 times with left leg stepping first with 3 sets of 5 repetitions Throwing and Catching Ball: Using a soft volleyball with 3 sets of 5 repetitions
Warm-Up: Active/passive ROM exercises for upper and lower limbs, 3 days/week for 10-15 minutes Trunk Control Exercises: Bridging, pelvic tilts, seated trunk rotations, reaching tasks with 3 sets of 5 repetitions for 3 days/week for 20 minutes Strengthening Exercises: Resistance band work for lower limb extensors, upper limb flexors with 3 sets of 5 repetitions for 3 days/week for 15-20 minutes Stretching: Hamstrings, calf, hip flexors, upper trapezius with 3 sets of 5 repetitions for 3 days/week for 10 minutes Postural Control Training: Use of Swiss ball, sitting on unstable surfaces, dual-task exercises with 3 sets of 5 repetitions for 3 days/week for 15-20 minutes Gait Training: Parallel bar walking, overground ambulation, obstacle walking 3 sets of repetitions for 3 days/week for 15-20 minutes Cool Down: Deep breathing, guided relaxation with 3 days/week for 5-10 minutes Education: Fall prevention, safe transfers, home exercise program with weekly session for 10-15 minutes
|
|
Comparador Ativo: Balance training and conventional physical therapy
|
Sitting-to-Standing: Performed using a stool with 3 sets of 5 repetitions Lateral Stepping: Walk 3 meters back and forth sideways with 3 sets of 5 repetitions Forward and Backward Stepping: 5 times with right leg stepping first, 5 times with left leg stepping first with 3 sets of 5 repetitions Forward Walking: Walk 3 meters back and forth, turn right at one end and left at the other wit 3 sets of 5 repetitions Stepping Up and Down: 5 times with right leg stepping first, 5 times with left leg stepping first with 3 sets of 5 repetitions Throwing and Catching Ball: Using a soft volleyball with 3 sets of 5 repetitions
Warm-Up: Active/passive ROM exercises for upper and lower limbs, 3 days/week for 10-15 minutes Trunk Control Exercises: Bridging, pelvic tilts, seated trunk rotations, reaching tasks with 3 sets of 5 repetitions for 3 days/week for 20 minutes Strengthening Exercises: Resistance band work for lower limb extensors, upper limb flexors with 3 sets of 5 repetitions for 3 days/week for 15-20 minutes Stretching: Hamstrings, calf, hip flexors, upper trapezius with 3 sets of 5 repetitions for 3 days/week for 10 minutes Postural Control Training: Use of Swiss ball, sitting on unstable surfaces, dual-task exercises with 3 sets of 5 repetitions for 3 days/week for 15-20 minutes Gait Training: Parallel bar walking, overground ambulation, obstacle walking 3 sets of repetitions for 3 days/week for 15-20 minutes Cool Down: Deep breathing, guided relaxation with 3 days/week for 5-10 minutes Education: Fall prevention, safe transfers, home exercise program with weekly session for 10-15 minutes
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Berg Balance Scale
Prazo: Baseline and 8th week
|
The BBS is a 14-item measure used to assess functional mobility, static balance, and dynamic balance excluding ambulation.
However, BBS scores have also been correlated with stroke patient's motor and functional performance.
Scores range on an ordinal scale from zero (indicating need for assistance to minimally perform the task) to four (indicating independent performance of the task); with a maximum possible score of 56.
Historically, a score below 45/56 is typically indicative of increased fall risk.
|
Baseline and 8th week
|
|
Trunk Impairment Scale
Prazo: Baseline and 8th week
|
The original version of Trunk Impairment Scale (TIS) was developed by in 2004.
It comprises 17 items (scored on a 2, 3 or 4-point ordinal scale) and evaluates static and dynamic sitting, balance and trunk coordination.
The total score ranges from minimum 0 to maximum 23 points, a higher score indicating a better performance.
|
Baseline and 8th week
|
|
Postural Assessment Scale for Stroke
Prazo: Baseline and 8th week
|
The Postural Assessment Scale for Stroke (PASS) is a scale developed specifically for stroke patients.
It examines the patient's ability to maintain or change a given lying, sitting or standing posture, is easy to administer in the clinic and applicable to all patients, even those with very poor postural performance.
It contains 12 items of varying difficulty for assessing ability to maintain or change a given lying, sitting, or standing posture.
The items are assessed on a 4 level (0-3 point) rating scale.
The score ranges from a minimum of 0 (worst performance) to a maximum of 36 (best performance).
|
Baseline and 8th week
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hira Jabeen, Riphah International University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- REC/RCR & AHS/25/0233
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em AVC Subagudo
-
Beijing Friendship HospitalAtivo, não recrutando
-
Tanta UniversityConcluídoFratura sub-condilar mandibularEgito
-
University of CopenhagenVentriJect ApS; University of Southern DenmarkConcluídoJogadores de futebol de sub-eliteDinamarca
-
Wagner Macula & Retina CenterThromboGenicsRescindidoTração vitreomacular | Edema sub-retinianoEstados Unidos
-
Northwestern UniversityRecrutamentoMudanças no comportamento olfativo em diferentes contextos associados a diferentes sub -regiões da amígdalaEstados Unidos
-
Centre Hospitalier Universitaire DijonConcluídoHematoma sub-retiniano ligado à DMRIFrança
-
King George's Medical UniversityUnited States Agency for International Development (USAID)ConcluídoDesnutrição | Sub-cinco | Infestação por vermesÍndia
-
Minia UniversityConcluídoRetinopatia Serosa Central Aguda com Líquido Sub-retinianoEgito
-
Federico II UniversityConcluídoA presença de líquido sub -retiniano (SRF)Itália
-
Shanghai Cell Therapy Group Co.,LtdShanghai Mengchao Cancer HospitalAinda não está recrutandoHiperlipidemia | Sub-saudável | Acúmulo de íons metálicos tóxicosChina
Ensaios clínicos em rhythmic breathing exercise
-
Riphah International UniversityConcluído
-
Yunnan Cancer HospitalRecrutamento