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Walking Training After Lumbar Decompression Surgery

2026年11月9日 更新者:salih tan、Istanbul Medipol University Hospital

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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

30年~65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
アクティブコンパレータ: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.

実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Functional Gait Assessment (FGA) Total Score at Week 8
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Timed Up and Go (TUG) Test Time
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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)
時間枠: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

その他の成果指標

結果測定
メジャーの説明
時間枠
Functional Gait Assessment (FGA) Total Score at Week 4
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年11月25日

一次修了 (推定)

2027年1月25日

研究の完了 (推定)

2027年1月25日

試験登録日

最初に提出

2026年11月9日

QC基準を満たした最初の提出物

2026年11月9日

最初の投稿 (実際)

2026年11月13日

学習記録の更新

投稿された最後の更新 (実際)

2026年11月13日

QC基準を満たした最後の更新が送信されました

2026年11月9日

最終確認日

2026年11月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • IMU-LD-GAIT-2026

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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.

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いいえ

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いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。