Walking Training After Lumbar Decompression Surgery
Effectiveness of Task-Specific Gait Training After Lumbar Decompression: An Assessor-Blinded Randomized Controlled Trial
This study will test whether adding walking practice to standard rehabilitation improves balance while walking after lower back surgery. The study will include 60 adults aged 30 to 65 who still have difficulty walking or keeping their balance after surgery to relieve pressure on the nerves in the lower back caused by a narrowing of the spinal canal.
Participants will be assigned by chance to one of two groups. One group will receive standard rehabilitation. The other group will receive the same rehabilitation plus extra practice with everyday walking tasks, such as changing speed, turning, and stepping over obstacles. Both groups will attend three supervised sessions per week for eight weeks.
Participants will be assessed before starting the program and again at weeks 4 and 8. The person who performs the assessments will be unaware of each participant's group assignment. The main outcome is balance during walking tasks at week 8. The study will also assess walking speed and distance, the ability to get up from a chair and move around, back and leg pain, and how back problems affect daily activities.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
This is an assessor-blinded, parallel-group randomized controlled trial in adults with persistent walking or balance difficulties after lumbar decompression without fusion for lumbar spinal stenosis. Baseline assessments will take place 6 to 12 weeks after surgery, before randomization. Participants will be assigned in a 1:1 ratio to standard rehabilitation or standard rehabilitation plus task-specific gait training.
The additional training will be progressed according to each participant's ability to complete the walking tasks safely and without a marked increase in symptoms. The comparison will estimate the effect of adding the training program to standard rehabilitation, including the additional exercise time and therapist contact.
The primary analysis will compare Functional Gait Assessment (FGA) total scores at week 8 between groups, adjusting for baseline FGA scores. Weeks 4 and 8 are measured from the start of the rehabilitation program. Week 4 assessments are exploratory. Adverse events will be monitored and documented throughout the intervention period.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: MEHMET SALİH TAN, PhD
- Número de telefone: +90 546 726 68 76
- E-mail: mstan@medipol.edu.tr
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age 30-65 years, inclusive.
- Primary lumbar decompression without fusion for lumbar spinal stenosis.
- Baseline assessment 6-12 weeks after surgery.
- Surgeon clearance for exercise and physical performance testing.
- Self-reported walking difficulty and at least one walking-task limitation documented at screening.
- Able to walk at least 10 meters without another person's physical assistance, with or without a walking aid.
- Able to understand test instructions.
- Agrees to the 8-week program and all 3 assessments.
- Provides written informed consent.
Exclusion Criteria:
- Spinal fusion or instrumentation at decompression, or revision surgery in the same lumbar region.
- Active wound infection, ongoing cerebrospinal fluid leak, or a postoperative complication preventing exercise.
- Progressive neurological deficit, signs of cauda equina syndrome, or need for surgical reassessment.
- Neurological condition that independently affects walking, such as stroke, Parkinson disease, multiple sclerosis, or significant peripheral neuropathy.
- Advanced hip or knee disease, recent lower-limb fracture, or major lower-limb surgery that substantially affects walking.
- Uncontrolled vestibular disorder or severe uncorrected visual impairment.
- Cardiovascular, pulmonary, or systemic disease that a physician considers a contraindication to exercise or testing.
- Active malignancy, spinal infection, or acute vertebral fracture.
- Concurrent structured gait and balance rehabilitation.
- Pregnancy.
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 |
|---|---|
|
Comparador Ativo: Standard Rehabilitation
Participants will receive approximately 40 minutes of supervised standard rehabilitation per session, three times per week for eight weeks. They will also receive the standard home exercise program. |
The supervised program includes a warm-up, trunk control exercises, lower-limb strengthening, flexibility and mobility exercises, comfortable walking on a level and unobstructed surface, and a cool-down. Exercises are individualized according to postoperative restrictions, symptoms, and movement quality. Both groups receive the same home program, which takes approximately 15 to 20 minutes and is performed three days per week. |
|
Experimental: Standard Rehabilitation Plus Task-Specific Gait Training
Participants will receive the same supervised standard rehabilitation and home exercise program as the active comparator group. Each supervised session will also include approximately 20 minutes of task-specific gait training, for a total of approximately 60 minutes per session, three times per week for eight weeks. |
The supervised program includes a warm-up, trunk control exercises, lower-limb strengthening, flexibility and mobility exercises, comfortable walking on a level and unobstructed surface, and a cool-down. Exercises are individualized according to postoperative restrictions, symptoms, and movement quality. Both groups receive the same home program, which takes approximately 15 to 20 minutes and is performed three days per week. The additional supervised training includes starting and stopping, changing walking speed and step length, turning, side-stepping, and stepping over obstacles. Tasks progress from individual skills to courses that combine multiple walking tasks. Difficulty is adjusted according to each participant's ability to complete the tasks safely and without a marked increase in symptoms. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Functional Gait Assessment (FGA) Total Score at Week 8
Prazo: Week 8 after the start of the rehabilitation program
|
The Functional Gait Assessment evaluates balance during 10 walking tasks. Each item is scored from 0 to 3, yielding a total score from 0 to 30. Higher scores indicate better walking balance. The primary analysis will compare week 8 scores between groups, adjusting for baseline FGA scores. |
Week 8 after the start of the rehabilitation program
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Timed Up and Go (TUG) Test Time
Prazo: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
|
Time in seconds to rise from a chair, walk 3 meters, turn, walk back, and sit down. The mean of two timed trials will be used. Shorter times indicate better functional mobility. |
Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
|
|
Comfortable Walking Speed on the 10-Meter Walk Test
Prazo: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
|
Walking speed at a self-selected comfortable pace, measured in meters per second over the middle 10 meters of a 14-meter walkway. The mean speed from two timed trials will be used. Higher values indicate faster walking. |
Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
|
|
Fast Walking Speed on the 10-Meter Walk Test
Prazo: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
|
Walking speed at the fastest safe pace without running, measured in meters per second over the middle 10 meters of a 14-meter walkway. The mean speed from two timed trials will be used. Higher values indicate faster walking. |
Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
|
|
Six-Minute Walk Test Distance
Prazo: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
|
Total distance walked in six minutes on a level 30-meter corridor, recorded in meters. The clock continues during rest breaks. Greater distance indicates better walking capacity. |
Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
|
|
Five Times Sit-to-Stand Test Time
Prazo: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
|
Time in seconds from the start command to reaching full standing on the fifth repetition. The mean of two timed trials will be used. Shorter times indicate better sit-to-stand performance. |
Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
|
|
Oswestry Disability Index (ODI) Score
Prazo: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
|
A 10-section questionnaire assessing how low back problems affect daily activities. Each section is scored from 0 to 5, and the total is expressed as a percentage from 0% to 100%. Higher scores indicate greater disability. |
Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
|
|
Low Back Pain Intensity on the Numeric Rating Scale (NRS)
Prazo: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
|
Participant-reported average low back pain intensity over the past 24 hours, rated from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity. |
Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
|
|
Leg Pain Intensity on the Numeric Rating Scale (NRS)
Prazo: Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
|
Participant-reported average leg pain intensity over the past 24 hours, rated from 0 (no pain) to 10 (worst pain imaginable). Higher scores indicate greater pain intensity. |
Baseline before the rehabilitation program and weeks 4 and 8 after the start of the program
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Functional Gait Assessment (FGA) Total Score at Week 4
Prazo: Week 4 after the start of the rehabilitation program
|
Exploratory assessment of walking balance using the 10-item Functional Gait Assessment. Total scores range from 0 to 30, with higher scores indicating better walking balance. |
Week 4 after the start of the rehabilitation program
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
- IMU-LD-GAIT-2026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
There is no current plan to share individual participant data. Any future request would be considered on a case-by-case basis, subject to applicable ethics, institutional, and data protection requirements.
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 .